The following data is part of a premarket notification filed by Hand Innovations, Inc. with the FDA for Hand Innovations, Inc. Distal Radius Fracture Repair System.
| Device ID | K030198 |
| 510k Number | K030198 |
| Device Name: | HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | HAND INNOVATIONS, INC. 510 STONEMONT DR. Weston, FL 33326 |
| Contact | Richard D Bliss, Jr. |
| Correspondent | Richard D Bliss, Jr. HAND INNOVATIONS, INC. 510 STONEMONT DR. Weston, FL 33326 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-21 |
| Decision Date | 2003-04-01 |
| Summary: | summary |