Case 3:18-cv-00347-CAB-MDD Document 300-3 Filed 01/08/21 PageID.26954 Page 1 of 4
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`EXHIBIT 2
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`EXHIBIT 2 - Page 17
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`Case 3:18-cv-00347-CAB-MDD Document 300-3 Filed 01/08/21 PageID.26955 Page 2 of 4
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`Is 4 DEPARTMENT OF HEALTH & HUMAN SERVICES
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`\ft=
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`Public Health Service
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`Food and Drug Administration
`9200 Corporate Boulevard
`Rockville MD 20850
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`OCT 7 - 2003
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`Ms. Laetitia Bernard
`Manager of Regulatory Affairs and Quality Assurance
`NuVasive, Inc.
`10065 Old Grove Road, Suite A
`San Diego, CA 92131
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`Re: K032180
`Trade/Device Name: NuVasive® Cement Restrictor
`Regulation Number: 21 CFR 878.3300
`Regulation Name: Surgical Mesh
`Regulatory Class: II
`Product Code: JDK
`Dated: July 16, 2003
`Received: July 17, 2003
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`Dear Ms. Bernard:
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`We have reviewed your Section 510(k) premarket notification of intent to market the device
`referenced above and have determined the device is substantially equivalent (for the indications
`for use stated in the enclosure) to legally marketed predicate devices marketed in interstate
`commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to
`devices that have been reclassified in accordance with the provisions of the Federal Food, Drug,
`and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls
`provisions of the Act and the limitations described below. The general controls provisions of the
`Act include requirements for annual registration, listing of devices, good manufacturing practice.
`labeling, and prohibitions against misbranding and adulteration.
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`The Office of Device Evaluation has determined that there is a reasonable likelihood that this
`device will be used for an intended use not identified in the proposed labeling and that such use
`could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following
`limitation must appear in the device's labeling:
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`WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS.
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`THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN
`THE SPINE HAVE NOT BEEN ESTABLISHED.
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`Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act.
`Therefore, a new 510(k) is required before these limitations are modified in any way or removed
`from the device's labeling.
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`Highly Confidential - Outside Attorney's Eyes Only
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`NUVA_ATEC0338292
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`EXHIBIT 2 - Page 18
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`Case 3:18-cv-00347-CAB-MDD Document 300-3 Filed 01/08/21 PageID.26956 Page 3 of 4
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`Page 2 - Ms. Laetitia Bernard
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`The FDA finding of substantial equivalence of your device to a legally marketed predicate
`device results in a classification for your device and permits your device to proceed to the
`market. This letter will allow you to begin marketing your device as described in your Section
`510(k) premarket notification if the limitation statement described above is added to your
`labeling.
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`If your device is classified (see above) into either class II (Special Controls) or class III (PMA),
`it may be subject to additional controls. Existing major regulations affecting your device can be
`found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may
`publish further announcements concerning your device in the Federal Register.
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`Please be advised that FDA's issuance of a substantial equivalence determination does not mean
`that FDA has made a determination that your device complies with other requirements of the Act
`or any Federal statutes and regulations administered by other Federal agencies. You must
`comply with all the Act's requirements, including, but not limited to: registration and listing (21
`CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
`forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
`product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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`If you desire specific information about the application of other labeling requirements to your
`device (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also,
`please note the regulation entitled, "Misbranding by reference to premarket notification" (21
`CFR Part 807.97). You may obtain other general information on your responsibilities under the
`Act from the Division of Small Manufacturers, International, and Consumer Assistance at its
`toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
`http://www.fda.gov/cdrhidsma/dsmamain.html.
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`Sincerely
`
`Daniel Schultz, M.D.
`Director
`Office of Device Evaluation
`Center for Devices and
`Radiological Health
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`Enclosure
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`Highly Confidential - Outside Attorney's Eyes Only
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`NUVA_ATEC0338293
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`EXHIBIT 2 - Page 19
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`Case 3:18-cv-00347-CAB-MDD Document 300-3 Filed 01/08/21 PageID.26957 Page 4 of 4
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`Page 1 of 1
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`510(k) Number (if known): K032180
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`Device Name: NuVasive® Cement Restrictor
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`FDA's Statement of the Indications For Use for device:
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`The NuVasive® Cement Restrictor is indicated for use as a cement restrictor in the femur, tibia,
`and/or humerus.
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`This device is not intended for spinal indications. The safety and effectiveness of this device
`when implanted in the spine have not been established.
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`1r\ (Division Sign-Off)
`Division of General, Restorative
`and Neurological Devices
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`510(k) Number
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`)1/4Z03 Dd.()
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`Highly Confidential - Outside Attorney's Eyes Only
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`NUVA_ATEC0338294
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`EXHIBIT 2 - Page 20
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