510(k) K020377 ยท HWC Screw, Fixation, Bone
PRE-LOADED BIOSTINGER HORNET
| Applicant | Linvatec Corp., Largo FL, US |
| Decision | Substantially Equivalent, May 6, 2002 |
| Received | Feb 5, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020377
| 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*** QTY 1***Hornet Disposable Inserter, BioStinger Implant***STERILE***Linvatec, LINVATEC CORPORATION Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.