SEQUOIA SPINAL SYSTEM, MODEL 3300 SERIES
FDA 510(k) clearance K072672 · decided 2007-11-28
Clearance details
- K-number
- K072672
- Device name
- SEQUOIA SPINAL SYSTEM, MODEL 3300 SERIES
- Applicant
- Abbott Spine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-09-21
- Decision date
- 2007-11-28
- Days to decision
- 68 days
- Clearance type
- Special
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Abbott 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 |
|---|---|---|
| Sequoia final driver closure top retention, non-sterile, REF 3384-2, Zimmer Spine, Austin, recall (Z-2705-2011) | Zimmer Inc. | 2011-06-29 |
| Sequoia Spinal System Surgical Kits; Pedicle screw spinal system; Non-sterile (kits intend recall (Z-1479-2008) | Abbott Spine | 2008-07-23 |