510(k) K041081 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES
| Applicant | Hand Innovations, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Jul 1, 2004 |
| Received | Apr 26, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041081
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2014 | Biomet, Inc. Device Brand Name: Distal Radius Fracture Repair System
Device Classification Name: Plate, Fixation, Bone
Device Common Name: Drill Guide DNP 3.3mm
Labeling: DRILL GUIDE DNP 3.3 MM NON-STERILE LOT NB0 Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.