510(k) K041261 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
FEMORAL HOOK
| Applicant | Arthrotek, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jun 7, 2004 |
| Received | May 11, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041261
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2008 | Biomet Sports Medicine BIOMET EZLoc 7-8mm TM Femoral Fixation, Catalog Number 904780. The Ezloc Is indicated for use for fixation of tendons & ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Terminated |
MBI | None listed |
| Sep 4, 2008 | Biomet Sports Medicine BIOMET EZLoc 9-10mm TM Femoral Fixation, Catalog Number 904781. The Ezloc Is indicated for use for fixation of tendons & ligaments during orthopedic reconstruction procedures such as Anterior Crucia Terminated |
MBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.