The following data is part of a premarket notification filed by Stuckenbrock Medizintechnik Gmbh with the FDA for Herbert Ulnar Head Prosthesis System.
| Device ID | K042902 |
| 510k Number | K042902 |
| Device Name: | HERBERT ULNAR HEAD PROSTHESIS SYSTEM |
| Classification | Prosthesis, Wrist, Hemi-, Ulnar |
| Applicant | STUCKENBROCK MEDIZINTECHNIK GMBH 12244 SW 130 ST. Miami, FL 33186 |
| Contact | Al Weisenborn |
| Correspondent | Al Weisenborn STUCKENBROCK MEDIZINTECHNIK GMBH 12244 SW 130 ST. Miami, FL 33186 |
| Product Code | KXE |
| CFR Regulation Number | 888.3810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-20 |
| Decision Date | 2004-12-27 |
| Summary: | summary |