SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310)
FDA 510(k) clearance K082032 · decided 2008-10-06
Clearance details
- K-number
- K082032
- Device name
- SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310)
- Applicant
- Abbott Spine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-07-17
- Decision date
- 2008-10-06
- Days to decision
- 81 days
- Clearance type
- Traditional
- 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
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Zimmer / Abbott Spine Sequoia dorsal height & revision tool, non-sterile; REF 3367-1. Surg recall (Z-0554-2010) | Zimmer Inc. | 2009-12-22 |