The following data is part of a premarket notification filed by Kinetikos Medical, Inc. with the FDA for Kmi Wrist Fusion System.
| Device ID | K990094 |
| 510k Number | K990094 |
| Device Name: | KMI WRIST FUSION SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | KINETIKOS MEDICAL, INC. 4115 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Contact | Michael Collins |
| Correspondent | Michael Collins KINETIKOS MEDICAL, INC. 4115 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-12 |
| Decision Date | 1999-02-18 |
| Summary: | summary |