The following data is part of a premarket notification filed by Acumed Llc with the FDA for Acumed Wrist Arthrodesis Plate System.
| Device ID | K100123 |
| 510k Number | K100123 |
| Device Name: | ACUMED WRIST ARTHRODESIS PLATE SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | ACUMED LLC 5885 NW CORNELIUS PASS RD. Hillsboro, OR 97124 -9432 |
| Contact | Lino Tsai |
| Correspondent | Lino Tsai ACUMED LLC 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 | 2010-01-15 |
| Decision Date | 2010-10-06 |
| Summary: | summary |