510(k) K010690 ยท DZL Screw, Fixation, Intraosseous
SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, May 18, 2001 |
| Received | Mar 8, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010690
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 17, 2013 | Synthes USA HQ, Inc. Multi Vector Distractor Pin Holding Clamp, limited bone stock
The holding clamp is part of the Multi Vector Distractor which cis used for mandibular bone lengthening, including conditions such as con Terminated |
DZL | None listed |
| Mar 1, 2013 | Synthes USA HQ, Inc. Synthes Multi-Vector Distractor Body, Part Number 487.931.
For mandibular bone lengthening. Terminated |
DZL | None listed |
| Mar 1, 2013 | Synthes USA HQ, Inc. Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966.
For mandibular bone lengthening. Terminated |
DZL | None listed |
| Mar 1, 2013 | Synthes USA HQ, Inc. Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967.
For mandibular bone lengthening. Terminated |
DZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.