510(k) K952296 ยท HWC Screw, Fixation, Bone
SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREW
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, Aug 18, 1995 |
| Received | May 16, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952296
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2017 | MicroPort Orthopedics Inc. MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R
Product Usage:
MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain a Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.