The following data is part of a premarket notification filed by Kinetikos Medical, Inc. with the FDA for Kmi Distal Volar Radius Plate System.
| Device ID | K041461 |
| 510k Number | K041461 |
| Device Name: | KMI DISTAL VOLAR RADIUS PLATE SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | KINETIKOS MEDICAL, INC. 6005 HIDDEN VALLEY RD, STE 180 Carlsbad, CA 92011 |
| Contact | John G Spampinato |
| Correspondent | John G Spampinato KINETIKOS MEDICAL, INC. 6005 HIDDEN VALLEY RD, STE 180 Carlsbad, CA 92011 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-02 |
| Decision Date | 2004-08-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M248281350181 | K041461 | 000 |
| M248271427221 | K041461 | 000 |
| M248271427141 | K041461 | 000 |
| M248271427101 | K041461 | 000 |
| M248281350161 | K041461 | 000 |
| M248281350121 | K041461 | 000 |
| M248280066011 | K041461 | 000 |
| M248280064011 | K041461 | 000 |
| M248271427301 | K041461 | 000 |
| M248271427201 | K041461 | 000 |
| M248271427181 | K041461 | 000 |
| M248271427161 | K041461 | 000 |
| M248271427121 | K041461 | 000 |
| M248271427061 | K041461 | 000 |
| M248271427081 | K041461 | 000 |
| M248281350141 | K041461 | 000 |
| M248281350101 | K041461 | 000 |
| M24828135081 | K041461 | 000 |
| M248280066021 | K041461 | 000 |
| M248280064021 | K041461 | 000 |
| M248271427381 | K041461 | 000 |
| M248271427361 | K041461 | 000 |
| M248271427341 | K041461 | 000 |
| M248271427321 | K041461 | 000 |
| M248271427281 | K041461 | 000 |
| M248271427261 | K041461 | 000 |
| M248271427241 | K041461 | 000 |
| M268VIPERSET0 | K041461 | 000 |