The following data is part of a premarket notification filed by Avanta Orthopaedics, Inc. with the FDA for Avanta Carpal Fusion Plating System.
| Device ID | K030881 |
| 510k Number | K030881 |
| Device Name: | AVANTA CARPAL FUSION PLATING SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | AVANTA ORTHOPAEDICS, INC. 8600 EVERGREEN BLVD. Minneapolis, MN 55433 |
| Contact | H. Doug Plunkett |
| Correspondent | H. Doug Plunkett AVANTA ORTHOPAEDICS, INC. 8600 EVERGREEN BLVD. Minneapolis, MN 55433 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-20 |
| Decision Date | 2003-04-10 |
| Summary: | summary |