The following data is part of a premarket notification filed by Kinetikos Medical, Inc. with the FDA for Katalyst Radial Head Implant.
| Device ID | K032806 |
| 510k Number | K032806 |
| Device Name: | KATALYST RADIAL HEAD IMPLANT |
| Classification | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| 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 | KWI |
| CFR Regulation Number | 888.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-09 |
| Decision Date | 2004-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M2482216851 | K032806 | 000 |
| M248KATALYSTWANDIMP1 | K032806 | 000 |
| M248KATALYSTSET1 | K032806 | 000 |
| 00885556827352 | K032806 | 000 |
| 00885556827345 | K032806 | 000 |
| 00885556827338 | K032806 | 000 |
| 00885556827321 | K032806 | 000 |
| 00885556827314 | K032806 | 000 |
| 00885556827307 | K032806 | 000 |
| 00885556827482 | K032806 | 000 |
| 00885556827475 | K032806 | 000 |
| M2482259181 | K032806 | 000 |
| M2482259211 | K032806 | 000 |
| M2482216801 | K032806 | 000 |
| M2482216601 | K032806 | 000 |
| M2482218001 | K032806 | 000 |
| M2482216751 | K032806 | 000 |
| M2482216651 | K032806 | 000 |
| M2482214241 | K032806 | 000 |
| M2482214211 | K032806 | 000 |
| M2482214181 | K032806 | 000 |
| M2482216701 | K032806 | 000 |
| M2482259241 | K032806 | 000 |
| 00885556827468 | K032806 | 000 |