CAPSTONE PTC™ Spinal System 3993607
by Medtronic Sofamor Danek, Inc.
CAPSTONE PTC™ Spinal System 3993607 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 2 Apr 2016 (UDI-DI 00643169187252), 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 | Number00643169187252 | Date2 Apr 2016 | StatusListed |
Official records
- AccessGUDID record 00643169187252
- 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 00643169187252 listed 2 Apr 2016 Listed
Timeline
- Cleared FDA 510(k) K133205
- Listed FDA GUDID 00643169187252
- 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- Withdrawn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
- 3993607
- Primary DI / UDI-DI
- 00643169187252
- 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
Similar devices
Other devices filed under FDA product code MAX (Intervertebral fusion device with bone graft, lumbar).
- Eit Cellular Titanium Lumbar Cage - T/PLIF by EIT Emerging Implant Technologies GmbH
- Falcon Spacer by Synthes (USA) Products LLC
- MectaLIF by Medacta International
- Leva Spacer System by Spine Wave, Inc.
- Idys™- LIF 06532912-S by Clariance, Inc.
- Patriot Lumbar Spacers, Sustain Spacers by GLOBUS MEDICAL, INC.
- Concorde Lift by MEDOS INTERNATIONAL SARL
- Tritanium PL Cage by Stryker Corp.
- Avs A-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXX by Stryker Spine
- JULIET ® Ti LL JLT-PL 04 08-S by Spineart