510(k) K934469 ยท HWC Screw, Fixation, Bone
ARTHROTEK INTERFERENCE SCREW
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent for Some Indications, Feb 23, 1994 |
| Received | Sep 10, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934469
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2020 | Biomet, Inc. Titanium IFS, Item number 909680 - Product Usage: Bone to bone fixation. Terminated |
MBI | None listed |
| Jan 30, 2013 | Biomet, Inc. TUNNELOC ROUND HEAD INTERFERENCE SCREW
8MMX25MM
Biomet Sports Medicine manufactures a variety of internal fixation devices intended to aid in arthroscopic and orthopedic reconstructive procedures requ Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.