Surgical Mesh System
510(k) K053215
Surgical Mesh System is a Class II device made by Nuvasive, Inc., cleared under FDA 510(k) K053215 on 17 Jul 2006, 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 | NumberK053215 | Date17 Jul 2006 | StatusActive |
Official records
- FDA 510(k) database K053215
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- Withdrawn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
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Other devices filed under FDA product code FTL (Mesh, Surgical, Polymeric).
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