The following data is part of a premarket notification filed by Cutter Laboratories, Inc. with the FDA for Ulnar Head Prothesis.
| Device ID | K790125 |
| 510k Number | K790125 |
| Device Name: | ULNAR HEAD PROTHESIS |
| Classification | Prosthesis, Wrist, Hemi-, Ulnar |
| Applicant | CUTTER LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KXE |
| CFR Regulation Number | 888.3810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-01-23 |
| Decision Date | 1979-02-08 |