The following data is part of a premarket notification filed by Orthomedics with the FDA for Ulnar Fracture Brace.
| Device ID | K802908 |
| 510k Number | K802908 |
| Device Name: | ULNAR FRACTURE BRACE |
| Classification | Orthosis, Limb Brace |
| Applicant | ORTHOMEDICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IQI |
| CFR Regulation Number | 890.3475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-17 |
| Decision Date | 1980-12-17 |