The following data is part of a premarket notification filed by Kinetikos Medical, Inc. with the FDA for Universal Total Wrist System (modification).
| Device ID | K961051 |
| 510k Number | K961051 |
| Device Name: | UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION) |
| Classification | Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained |
| Applicant | KINETIKOS MEDICAL, INC. 3950 SORRENTO VALLEY BLVD., San Diego, CA 92121 |
| Contact | Mark G Urbanski |
| Correspondent | Mark G Urbanski KINETIKOS MEDICAL, INC. 3950 SORRENTO VALLEY BLVD., San Diego, CA 92121 |
| Product Code | JWJ |
| CFR Regulation Number | 888.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-11 |
| Decision Date | 1996-06-06 |
| Summary: | summary |