510(k) K051734 ยท HAW Neurological Stereotaxic Instrument
GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955
| Applicant | Ge Healthcare Technologies, Lawrence MA, US |
| Decision | Substantially Equivalent, Nov 23, 2005 |
| Received | Jun 28, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051734
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 11, 2012 | GE OEC Medical Systems, Inc The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is a self-tapping, self-drilling screw and is an accessory used in conjunction with the Axcess Cranial Tri-Pin Kit.
The Axce Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.