Zavation Cervical Plate System
510(k) K130030
Zavation Cervical Plate System is a Class II device made by Zavation LLC, cleared under FDA 510(k) K130030 on 25 Apr 2013, 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 | NumberK130030 | Date25 Apr 2013 | StatusActive |
Official records
- FDA 510(k) database K130030
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KWQ
- FDA applicant
- Zavation, LLC
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3060
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K130030
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Zavation 150-0230 | 150-0230 | 00842166109209 | — | On the market |