Nuvasive Surgical Mesh System
510(k) K081377
Nuvasive Surgical Mesh System is a Class II device made by Nuvasive, Inc., cleared under FDA 510(k) K081377 on 15 Jan 2009, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK081377 | Date15 Jan 2009 | StatusActive |
Official records
- FDA 510(k) database K081377
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FTL
- Device class
- Class II
- Regulation
- 21 CFR Part 878.3300
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code FTL (Mesh, Surgical, Polymeric).
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- Endoform Reconstructive Template by Aroa Biosurgery Limited (Formerly Mesynthes Limited)
- TEPHAFLEX SURGICAL FILM by Tepha, Inc.
- ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT by Atrium Medical Corp.
- GIANTURCO-HELFRICH HERNIS MESH by Cook, Inc.
- GORE-TEX SAM FACIAL IMPLANT WITH INTRODUCER by W. L. Gore & Associates, Inc.
- GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL by W. L. Gore & Associates, Inc.
- SPORTMESH by Artimplant AB