MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM
FDA 510(k) clearance K071380 · decided 2007-08-20
Clearance details
- K-number
- K071380
- Device name
- MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM
- Applicant
- Alphatec Spine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-05-17
- Decision date
- 2007-08-20
- Days to decision
- 95 days
- Clearance type
- Special
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Alphatec Spine
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Solanas Posterior Stabilization System Part Number: 63920. Solanas Posterior Stabilization recall (Z-0932-2012) | Alphatec Spine, Inc. | 2012-01-31 |
| Alphatec Spine Solanas Titanium Pedicle Screw, Part Number 63035-12 recall (Z-0502-2010) | Alphatec Spine, Inc. | 2009-12-14 |
| Alphatec Spine Solanas Titanium Pedicle Screw Part Number 63035-14 recall (Z-0503-2010) | Alphatec Spine, Inc. | 2009-12-14 |