510(k) K052248 ยท HRS Plate, Fixation, Bone
DORSAL NAIL PLATE, ANATOMICAL
| Applicant | Hand Innovations, LLC, Miami Lakes FL, US |
| Decision | Substantially Equivalent, Sep 14, 2005 |
| Received | Aug 18, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052248
| 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 |
| Feb 11, 2009 | Depuy Orthopaedics, Inc. DePuy DNP Anatomic Fracture Repair System, Locking Screw DNP Anatomic, Depuy, Warsaw, IN; REF DNPALS.
The device is used in the treatment of fractures and osteotomies of the distal radius. Terminated |
HRS | None listed |
| Feb 11, 2009 | Depuy Orthopaedics, Inc. DePuy DNP Anatomic Fracture Repair System, JIG DNP Anatomic, Depuy, Warsaw, IN; REF DNPAJIG.
The device is used in the treatment of fractures and osteotomies of the distal radius. Terminated |
HRS | None listed |
| Feb 11, 2009 | Depuy Orthopaedics, Inc. DePuy DNP Anatomic Fracture Repair System, DNP Anatomic Left, Depuy, Warsaw, IN; REF DNPAL.
The device is used in the treatment of fractures and osteotomies of the distal radius. Terminated |
HRS | None listed |
| Feb 11, 2009 | Depuy Orthopaedics, Inc. DePuy DNP Anatomic Fracture Repair System, DNP Anatomic Right, Depuy, Warsaw, IN; REF DNPAR.
The device is used in the treatment of fractures and osteotomies of the distal radius. Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.