Roc Lumbar System
510(k) K063668
Roc Lumbar System is a Class II device made by Alphatec Spine, Inc., cleared under FDA 510(k) K063668 on 18 May 2007, 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 | NumberK063668 | Date18 May 2007 | StatusActive |
Official records
- FDA 510(k) database K063668
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MNI
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code MNI (Orthosis, Spinal Pedicle Fixation).
- RELIANCE SPINAL SCREW SYSTEM by Reliance Medical Systems, LLC
- Erisma™-LP 18415506 by Clariance, Inc.
- Erisma®-LP 18158550 by Clariance, Inc.
- TRAVERSE OCT SPINAL FIXATION SYSTEM by MEDTRONIC SOFAMOR DANEK, INC.
- USS-LINE EXTENSION by Synthes
- INERTIA PEDICLE SCREW SYSTEM by NEXXT SPINE LLC
- Optima ZS Transition Screw by ZIMMER SPINE, INC.
- BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR by Blackstone Medical, Inc.
- SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM by Synthes Spine
- MODIFICATION TO STRYKER SPINE OASYS SYSTEM by Stryker Spine