The following data is part of a premarket notification filed by Acumed, Inc. with the FDA for Wrist Fusion Plate.
| Device ID | K021321 |
| 510k Number | K021321 |
| Device Name: | WRIST FUSION PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | ACUMED, INC. 5885 NW CORNELIUS PASS RD. Hillsboro, OR 97124 -9432 |
| Contact | Carrie Mcmichael |
| Correspondent | Carrie Mcmichael ACUMED, INC. 5885 NW CORNELIUS PASS RD. Hillsboro, OR 97124 -9432 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-25 |
| Decision Date | 2002-07-17 |
| Summary: | summary |