Premarket Approval (PMA)
`
`http://www.accessdata.fda.gov/scripts/cdIh/cfdocs/cfpma/pmacfrrflidz18239
`
`FDA Home3 Medical Devices4 Databases5
`
`
`
`lFiecallsmlPMA11 |C|assification12|Standards1allnspections14
`
`Premarket Approval (PM A)
`|Adverse
`’
`§
`@1o(k)7|Registration &
`Eventsg
`ListingB
`CFR Title 2115|Radiation~Emitting Products‘le—Flay AssemblerfllMedsun l=leports1alCLlA1gl'l'PLC20
`
`
`
`3‘
`
`‘
`
`New Searc
`
`h21
`
`Back to Search Results
`
`Note: this medical device record is a supplement. The device description may have
`changed. Be sure to look at the original PMA22 to get an up-to-date view of this
`device.
`
`Trade Name
`
`.
`.
`Classrficatlon Name
`
`BAK INTERBODY FUSION SYSTEM
`
`Intervertebral Fusion Device With Bone Graft,
`
`23
`Lumbar
`
`Generic Name
`Regulation Number
`Applicant
`PMA Number
`
`Lumbar Interbody Fusion Instrumentation
`888308024
`SPINE—TECH, INC.
`P950002
`
`Supplement Number 5002
`Date Received
`02/05/1997
`Decision Date
`05/09/1997
`Product Code
`MAX [ Registered Establishments With MAX25 ]
`Advisory Committee Orthopedic
`Supplement Type
`Real—time Process
`Supplement Reason ghfigfiqe Desrgn/components/specrflcations —
`Expedited Review
`No
`Granted?
`
`Combination Product No
`
`Approval Order Statement
`Approval of the addition of the following sizes to the bak product line: a)
`bak implants (minor diameter (mm) x length (mm)) 11x20, 11x24,
`11x28, 11x32, 11x36; 13x24, 13x28, 13x32, 13x36, 13x40; 15x28,
`15x32, 15x36, 15x40, 15x44; 17x20, 17x32, 17x36, 17x40, 17x44;
`19x24, 19x28, 19x32, 19x36, 19x40, 19x44; 21x28, 21x32, 21x36,
`21x40, 21x44; and (b) end caps (diameter (mm)) 11; 19; and 21.
`
`Links on this page:
`
`1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
`
`2. http://www.addthis.com/bookmark.php
`
`3. http://www.fda.gov/default.htm
`
`4. http://www.fda.gov/MedicalDevices/default.htm
`5 . http://www.fda.gov/Medical Devices/DeviceReguIationandGu idance/Databases
`/default.htm
`
`6.
`
`/scripts/cdrh/devicesatfda/index.cfm
`
`1 of3
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`MSD 1118
`|PR2013-00506
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`|PR2013-00508
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`7/31/2014 10:56 AM
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`
`
`http://www.accessdata.fda.gov/scripts/cdIh/cfdocs/cfpma/pmacfrrflidz18239
`
`FDA Home3 Medical Devices4 Databases5
`
`
`
`lFiecallsmlPMA11 |C|assification12|Standards1allnspections14
`
`Premarket Approval (PM A)
`|Adverse
`’
`§
`@1o(k)7|Registration &
`Eventsg
`ListingB
`CFR Title 2115|Radiation~Emitting Products‘le—Flay AssemblerfllMedsun l=leports1alCLlA1gl'l'PLC20
`
`
`
`3‘
`
`‘
`
`New Searc
`
`h21
`
`Back to Search Results
`
`Note: this medical device record is a supplement. The device description may have
`changed. Be sure to look at the original PMA22 to get an up-to-date view of this
`device.
`
`Trade Name
`
`.
`.
`Classrficatlon Name
`
`BAK INTERBODY FUSION SYSTEM
`
`Intervertebral Fusion Device With Bone Graft,
`
`23
`Lumbar
`
`Generic Name
`Regulation Number
`Applicant
`PMA Number
`
`Lumbar Interbody Fusion Instrumentation
`888308024
`SPINE—TECH, INC.
`P950002
`
`Supplement Number 5002
`Date Received
`02/05/1997
`Decision Date
`05/09/1997
`Product Code
`MAX [ Registered Establishments With MAX25 ]
`Advisory Committee Orthopedic
`Supplement Type
`Real—time Process
`Supplement Reason ghfigfiqe Desrgn/components/specrflcations —
`Expedited Review
`No
`Granted?
`
`Combination Product No
`
`Approval Order Statement
`Approval of the addition of the following sizes to the bak product line: a)
`bak implants (minor diameter (mm) x length (mm)) 11x20, 11x24,
`11x28, 11x32, 11x36; 13x24, 13x28, 13x32, 13x36, 13x40; 15x28,
`15x32, 15x36, 15x40, 15x44; 17x20, 17x32, 17x36, 17x40, 17x44;
`19x24, 19x28, 19x32, 19x36, 19x40, 19x44; 21x28, 21x32, 21x36,
`21x40, 21x44; and (b) end caps (diameter (mm)) 11; 19; and 21.
`
`Links on this page:
`
`1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
`
`2. http://www.addthis.com/bookmark.php
`
`3. http://www.fda.gov/default.htm
`
`4. http://www.fda.gov/MedicalDevices/default.htm
`5 . http://www.fda.gov/Medical Devices/DeviceReguIationandGu idance/Databases
`/default.htm
`
`6.
`
`/scripts/cdrh/devicesatfda/index.cfm
`
`1 of3
`
`MSD 1118
`|PR2013-00506
`
`|PR2013-00508
`
`7/31/2014 10:56 AM
`
`
`
`Premarket Approval (PMA)
`
`http://www.accessdata.fda.gov/soripts/cdrh/cfdocs/cfpma/pma.cfm?id=18239
`
`7.
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`/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
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`8.
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`/scripts/cdrh/cfdocs/chL/rl.cfm
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`9.
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`/scripts/cdrh/cfdocs/chAUDE/TextSearch.cfm
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`10. /scripts/cdrh/cfdocs/chES/res.cfm
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`11.
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`/scripts/cdrh/cfdocs/cfPMA/pma.cfm
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`12.
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`/scripts/cdrh/cfdocs/cfPCD/classification.cfm
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`/scripts/cdrh/cfdocs/cfStandards/search.cfm
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`/scripts/cdrh/cfdocs/chPLC/inspect.cfm
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`/scripts/cdrh/cfdocs/chFR/CFRSearch.cfm
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`/scripts/cdrh/cfdocs/cfPCD_RH/c|assification.cfm
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`/scripts/cdrh/cfdocs/cfAssem/assembler.cfm
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`/scripts/cdrh/cfdocs/Medsun/searchReportText.cfm
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`19. /scripts/cdrh/cfdocs/chlia/Search.cfm
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`20. /scripts/cdrh/cfdocs/chPLC/tplc.cfm
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`21.
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`/scripts/cdrh/cfdocs/cfpma/pma.cfm
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`22.
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`/scripts/cdrh/cfdocs/cfpma/pma.cfm?start_search=1&PMANumber=P950002&
`SupplementType=NONE
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`23.
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`/scri pts/cdrh/cfdocs/cfPCD/classifi cation .cfm?start_search = 1&ProductCode=MAX
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`24.
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`/scripts/cdrh/cfdocs/chFR/CFRSearch.cfm?FR=888.3080
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`25.
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`/scri pts/cdrh/cfdocs/chL/rl .cfm?sta rt_search = 1&establish mentName= &
`StateName=&CountryName=&RegistrationNumber=&OwnerOperatorNumber=&
`OwnerOperatorName=&ProductCode=MAX&DeviceName=&ProprietaryName=&
`establishmentType=&PAGENUM=5&SortColumn=
`
`Page Last Updated: 07/28/2014
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`Links on this page:
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`Premark 1 Approval (PMA)
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`http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pm.cfm?id=18239
`
`. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
`
`http://www.addthis.com/bookmark.php
`
`http://www.fda.gov/default.htm
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`http://www.fda.gov/MedicalDevices/default.htm
`
`http://www.fda.gov/Medical Devices/Devi ceRegulationandGuidance/Data bases
`/defau|t.htm
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`. /scripts/cdrh/devicesatfda/index.cfm
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`.U‘PWE‘JH
`LomVON
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`.
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`/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
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`/scripts/cdrh/cfdocs/chL/rl.cfm
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`. /scripts/cdrh/cfdocs/chAUDE/TextSearch.cfm
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`/scri pts/cdrh/cfdocs/cfPCD/cl assificati on .cfm
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`/scri pts/cdrh/cfdocs/cfStanda rds/sea rch .cfm
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`/scripts/cdrh/cfdocs/cFl'PLC/inspect.cfm
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`/scripts/cdrh/cfdocs/chFR/CFRSearch.cfm
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`/scri pts/cdrh/cfdocs/cfPCDwRH/cl assifi cati on .cfm
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`/scripts/cdrh/cfdocs/cfAssem/assembler.cfm
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`/scri pts/cdrh/cfdocs/Medsu n/sea rch ReportText.cfm
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`/scri pts/cdrh/cfdocs/chl i a/Sea rch .cfm
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`/scripts/cdrh/cfdocs/chPLC/tp!c.cfm
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`/scripts/cdrh/cfdocs/cfpma/pma.cfm
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`/scripts/cdrh/cfdocs/cfpma/pma.cfm?start_search=1&PMANumber=P950002&
`SupplementType=NONE
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`/scri pts/cdrh/cfdocs/cfPCD/cl assifi cati on .cfm ?sta rt_search = 1 &ProductCode= MAX
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`/scripts/cdrh/cfdocs/chFR/CFRSearch .cfm?FR=888.3080
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`/scri pts/cdrh/cfdocs/chL/rl .cfm?sta rt_search = 1&esta blish mentName=&
`StateName=&CountryName=&RegistrationNumber=&OwnerOperatorNumber=&
`Owner0peratorName=&ProductCode=MAX&DeviceName=&ProprietaryName=&
`establish mentType=&PAGENUM=5&SortCo|umn=
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