510(k) K082032 ยท NKB Thoracolumbosacral Pedicle Screw System
SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310)
| Applicant | Abbott Spine, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Oct 6, 2008 |
| Received | Jul 17, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082032
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2009 | Zimmer Inc. Zimmer / Abbott Spine Sequoia dorsal height & revision tool, non-sterile; REF 3367-1. Surgical instrument for pedicle screw system. Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.