The following data is part of a premarket notification filed by Kinetikos Medical, Inc. with the FDA for Modification To Universal Total Wrist System.
| Device ID | K020554 |
| 510k Number | K020554 |
| Device Name: | MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM |
| Classification | Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained |
| Applicant | KINETIKOS MEDICAL, INC. 4329 GRAYDON RD. San Diego, CA 92130 |
| Contact | Floyd G Larson |
| Correspondent | Floyd G Larson KINETIKOS MEDICAL, INC. 4329 GRAYDON RD. San Diego, CA 92130 |
| Product Code | JWJ |
| CFR Regulation Number | 888.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-20 |
| Decision Date | 2002-05-03 |
| Summary: | summary |