510(k) K013131 ยท HWC Screw, Fixation, Bone
BIOSCREW XTRALOK
| Applicant | Linvatec Corp., Largo FL, US |
| Decision | Substantially Equivalent, Jun 11, 2002 |
| Received | Sep 19, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013131
| 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 BioScrew XtraLok ***STERILE***Linvatec, LINVATEC CORPORATION LARGO, FL 33773 USA***''. Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.