The following data is part of a premarket notification filed by Hand Innovations, Inc. with the FDA for Distal Volar Radius Fracture Repair System.
| Device ID | K002775 |
| 510k Number | K002775 |
| Device Name: | DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | HAND INNOVATIONS, INC. 19526 EAST LAKE DR. Miami, FL 33015 |
| Contact | Al Weisenborn |
| Correspondent | Al Weisenborn HAND INNOVATIONS, INC. 19526 EAST LAKE DR. Miami, FL 33015 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-06 |
| Decision Date | 2000-12-05 |