510(k) K151580 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
D.N.E. External Fixation System
| Applicant | Dne, LLC, Slatington PA, US |
| Decision | Substantially Equivalent, Feb 16, 2016 |
| Received | Jun 11, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K151580
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 3, 2025 | Medshape, INC. Medshape Universal Joints, REF: DNE-9000-UJ Open, Classified |
KTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.