510(k) K083070 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
TOGGLELOC SYSTEM
| Applicant | Biomet Sports Medicine, Warsaw IN, US |
| Decision | Substantially Equivalent, Dec 16, 2008 |
| Received | Oct 15, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083070
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2017 | Zimmer Biomet, Inc. Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue. Terminated |
MBI | None listed |
| May 26, 2016 | Biomet, Inc. Various trauma and sports medicine instruments and implants.
Fastener, fixation, nondegradable, soft tissue. Terminated |
MBI | None listed |
| Jul 1, 2010 | Biomet, Inc. Artificial ligament fixation device # 7PE ZIPLOOP Extended Toggle, Sterile, REF 904755, Biomet Sports Medicine Warsaw, IN.
Intended for soft tissue to bone fixation. Terminated |
MBI | None listed |
| Jul 1, 2010 | Biomet, Inc. Toggleloc Artificial ligament fixation device ZIPLOOP Technology Implant Kit, Sterile, REF 909848, Biomet Sports Medicine Warsaw, IN.
Intended for soft tissue to bone fixation. Terminated |
MBI | None listed |
| Dec 22, 2009 | Biomet, Inc. Toggleloc System, Biomet Ziptight Ankle Syndesmosis Fixation System - Titanium with Ziploop Technology, polyethylene/polypropylene/ polyester/TI-6AL-4V alloy/S.S., sterile Biomet Sports Medicine, Wars Terminated |
MBI | None listed |
| Dec 22, 2009 | Biomet, Inc. Toggleloc System, Biomet Ziptight Ankle Syndesmosis Fixation System - SS with Ziploop Technology, polyethylene/polypropylene/ polyester/ stainless steel, sterile Biomet Sports Medicine, Warsaw, IN.; R Terminated |
MBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.