510(k) K041925 ยท KWP Appliance, Fixation, Spinal Interlaminal
ST360 SPINAL FIXATION SYSTEM
| Applicant | Zimmer Spine, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Sep 24, 2004 |
| Received | Jul 19, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041925
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 16, 2006 | Zimmer Spine, Inc. Zimmer Spine ST360 Distal Thread Reduction Guide Pins, Part number: 07.00684.00. Non-Sterile. Zimmer Spine, Inc., 7375 Bush Lake Road, Minneapolis, MN 55439 U.S.A. The Distal Thread Reduction Gui Terminated |
KWP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.