CAPSTONE PTC™ Spinal System 3992613
by Medtronic Sofamor Danek, Inc.
CAPSTONE PTC™ Spinal System 3992613 is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K172199 on 19 Sep 2017 (1 earlier submission) and listed in FDA GUDID since 17 Apr 2016 (UDI-DI 00643169187399), 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 | NumberK172199 | Date19 Sep 2017 | StatusActive |
| United States | GUDID listing | Number00643169187399 | Date17 Apr 2016 | StatusListed |
Official records
- AccessGUDID record 00643169187399
- FDA 510(k) database K172199
- FDA 510(k) database K133205
Across registries
- FDA 510(k) K172199 decided 19 Sep 2017 Active
- FDA GUDID UDI-DI 00643169187399 listed 17 Apr 2016 Listed
Timeline
- Cleared FDA 510(k) K133205
- Listed FDA GUDID 00643169187399
- Cleared FDA 510(k) K172199
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CAPSTONE PTC™ Spinal System
- Generic name
- Polymeric spinal interbody fusion cage
- Model / reference
- 3992613
- Primary DI / UDI-DI
- 00643169187399
- FDA product code
- MAX
- GMDN term
- Polymeric spinal interbody fusion cage
- Device class
- Class II
- Regulation number
- 888.3080
- GUDID distribution status
- In Commercial Distribution
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