The following data is part of a premarket notification filed by Acumed Llc with the FDA for Acumed Wrist Spanning Plate.
| Device ID | K131764 |
| 510k Number | K131764 |
| Device Name: | ACUMED WRIST SPANNING PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | ACUMED LLC 5885 NW Cornelius Pass Rd Hillsboro, OR 97124 |
| Contact | Nathan Wolf |
| Correspondent | Nathan Wolf ACUMED LLC 5885 NW Cornelius Pass Rd Hillsboro, OR 97124 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-17 |
| Decision Date | 2013-09-05 |
| Summary: | summary |