NUVASIVE SURGICAL MESH SYSTEM

{0}------------------------------------------------ # VII. 510(k) Summary In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular §807.92, the following summary of information is provided: #### A. Submitted by: Laetitia Cousin Director of Regulatory Affairs and Quality Assurance NuVasive, Incorporated 4545 Towne Centre Court San Diego, California 92121 Telephone: (858) 909-1868 Fax: (858) 909-2068 ## B. Device Name Trade or Proprietary Name: Common or Usual Name: Classification Name: Device Class: Classification: Product Code: NuVasive Surgical Mesh System Surgical Mesh Surgical Mesh Class II \$878.3300 FTL ## C. Predicate Devices The subject Surgical Mesh System is substantially equivalent to the Surgical Mesh System currently distributed commercially in the U.S. by NuVasive (K053215). ## D. Device Description The original NuVasive Surgical Mesh System consists of a series of specialized shapes and sizes of mostly flat embroidered mesh and a radiographic marker. The meshes typically contain pre-formed reinforced holes to provide secure and easy to find suture or tissue anchor locations. ## E. Intended Use The NuVasive Surgical Mesh System is intended to reinforce soft tissue where weakness exists. The device is intended for one-time use. K681377 1/2 {1}------------------------------------------------ K081377 2/2 # Comparison to Predicate Devices F. The subject device has indications for use identical to those of its predicate, and employs the same principles of operation. G. Summary of Non-Clinical Tests (Not Applicable). # H. Summary of Clinical Tests (Not Applicable). {2}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three bars representing the agency's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. # Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NuVasive, Inc. % Ms. Laetitia Cousin Senior Director, Regulatory & Clinical Affairs and Ouality Assurance 7475 Lusk Boulevard San Diego, California 92121 Re: K081377 Trade/Device Name: NuVasive Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: December 15, 2008 Received: December 16, 2008 Dear Ms. Cousin: 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 for use stated in the encreated of 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may a controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. 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 that I Drimas Intacted and regulations administered by other Federal agencies. You must or uny I vith 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 JAN 1 5 2009 {3}------------------------------------------------ Page 2 - Ms. Laetitia Cousin 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark N Millman Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): NuVasive Surgical Mesh Device Name: Indications For Use: The Surgical Mesh System is intended to be implanted to reinforce soft tissue where weakness exists. The device is intended for one-time use. Prescription Use X (Part 21 CFR 801 Subpart D) ﺔ ﺍﻟﺘﻲ ﺗﻌ AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Offige of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, and Neurological Devices Page 1 of 1 **510(k) Number** K081377