510(k) K042778 ยท HWC Screw, Fixation, Bone
BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE
| Applicant | Linvatec Corp., Largo FL, US |
| Decision | Substantially Equivalent, Nov 4, 2004 |
| Received | Oct 6, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042778
| 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 C6121H QTY 1 3.5 x 10.5 mm Bio-Anchor with Disposable Driver, Preloaded with One #2 Herculine Suture* Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.