510(k) K103145 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
HAMMERLOC TM TIBIAL FIXATION DEVICE
| Applicant | Biomet Sports Medicine, Warsaw IN, US |
| Decision | Substantially Equivalent, Feb 9, 2011 |
| Received | Oct 25, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103145
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 11, 2017 | Zimmer Biomet, Inc. TunneLoc Tibial Fixation Device
Product Usage:
To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reco Terminated |
MBI | None listed |
| Oct 11, 2017 | Zimmer Biomet, Inc. TunneLoc Tibial Fixation Device (Within an ACL Kit)
Product Usage:
To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate Terminated |
MBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.