The following data is part of a premarket notification filed by Kinetikos Medical, Inc. with the FDA for Kmi Wrist Fusion System.
| Device ID | K991873 |
| 510k Number | K991873 |
| 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 | 1999-06-02 |
| Decision Date | 1999-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556834640 | K991873 | 000 |
| 00885556834770 | K991873 | 000 |
| 00885556834787 | K991873 | 000 |
| 00885556834794 | K991873 | 000 |
| 00885556834800 | K991873 | 000 |
| 00885556834817 | K991873 | 000 |
| 00885556834824 | K991873 | 000 |
| 00885556834831 | K991873 | 000 |
| M2480728121 | K991873 | 000 |
| 00885556834763 | K991873 | 000 |
| 00885556834756 | K991873 | 000 |
| 00885556834749 | K991873 | 000 |
| 00885556834657 | K991873 | 000 |
| 00885556834664 | K991873 | 000 |
| 00885556834671 | K991873 | 000 |
| 00885556834688 | K991873 | 000 |
| 00885556834695 | K991873 | 000 |
| 00885556834701 | K991873 | 000 |
| 00885556834718 | K991873 | 000 |
| 00885556834725 | K991873 | 000 |
| M2480728161 | K991873 | 000 |
| M2480728101 | K991873 | 000 |
| M2480728141 | K991873 | 000 |
| M2480628161 | K991873 | 000 |
| M2480628181 | K991873 | 000 |
| M2480700051 | K991873 | 000 |
| M2480700061 | K991873 | 000 |
| M2480724081 | K991873 | 000 |
| M2480724101 | K991873 | 000 |
| M2480724141 | K991873 | 000 |
| M2480728061 | K991873 | 000 |
| M2480628141 | K991873 | 000 |
| M2480628121 | K991873 | 000 |
| M2480628101 | K991873 | 000 |
| M2480728181 | K991873 | 000 |
| M248SPIDERIMP1 | K991873 | 000 |
| M2480724121 | K991873 | 000 |
| M2480728081 | K991873 | 000 |
| M2480600051 | K991873 | 000 |
| M2480600061 | K991873 | 000 |
| M2480628061 | K991873 | 000 |
| M2480628081 | K991873 | 000 |
| M268SPIDERSET0 | K991873 | 000 |