510(k) K111376 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
CONSTRUX EXTERNAL FIXATION DEVICE
| Applicant | Ebi, LLC, Parsippany NJ, US |
| Decision | Substantially Equivalent, Aug 3, 2011 |
| Received | May 16, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111376
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 9, 2015 | Biomet, Inc. Unilateral external fixation ankle clamp
Product Usage:
Unilateral external fixation for use treatment of bone conditions amenable to treatment by use of external fixation modality Terminated |
KTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.