510(k) K130033 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TO
| Applicant | Biomet Manufacturing Corp, Warsaw IN, US |
| Decision | Substantially Equivalent, Aug 1, 2013 |
| Received | Jan 4, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130033
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 17, 2025 | Biomet, Inc. BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair Open, Classified |
MBI | None listed |
| 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 |
| Apr 2, 2015 | Biomet, Inc. ToggleLoc; fastener, fixation, non degradable, soft tissue; Artificial Ligament Fixation Device #7 PE Ziploop Extended Toggleloc
Product Usage:
The Toggleloc System is a non-resorbable system intende Terminated |
JDR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.