510(k) K033804 ยท HWC Screw, Fixation, Bone
BIOANCHOR WITH DISPOSABLE DRIVER
| Applicant | Linvatec Corp., Largo FL, US |
| Decision | Substantially Equivalent, Dec 31, 2003 |
| Received | Dec 8, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033804
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2005 | Linvatec Corp. Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF C6121 QTY 1 3.5mm Bio-Anchor with Disposable Driver***STERILE***Linvatec A ConMed Company LINVATEC CO Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.