510(k) K031985 ยท MNI Orthosis, Spinal Pedicle Fixation
SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM
| Applicant | Spinal Concepts, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Sep 11, 2003 |
| Received | Jun 27, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031985
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 10, 2010 | Zimmer Inc. Spinal Concepts polyaxial screw driver, AO, Manufactured by Spinal Concepts, Austin, TX, REF 775-01. Terminated |
KWQ | None listed |
| Dec 10, 2010 | Zimmer Inc. Spinal Concepts polyaxial screw driver, Manufactured by Spinal Concepts, Austin, TX, REF 781-01. Terminated |
KWQ | None listed |
| Dec 10, 2010 | Zimmer Inc. Spinal Concepts polyaxial screwdriver II, Manufactured by Spinal Concepts, Austin, TX, REF 781-2. Terminated |
KWQ | None listed |
| Dec 10, 2010 | Zimmer Inc. Spinal Concepts snap-fix polyaxial screwdriver, Manufactured by Spinal Concepts, Austin, TX, REF 781-3. Terminated |
KWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.