The following data is part of a premarket notification filed by Cartiva, Inc. with the FDA for Proxifuse Hammer Toe Device.
| Device ID | K142490 |
| 510k Number | K142490 |
| Device Name: | ProxiFuse Hammer Toe Device |
| Classification | Screw, Fixation, Bone |
| Applicant | Cartiva, Inc. 6120 Windward Parkway Alpharetta, GA 30005 |
| Contact | Richard Knostman |
| Correspondent | Rachel Kennedy Regulatory And Clinical Research Institute 5353 Wayzata Blvd, Suite 505 Minneapolis, MN 55416 -1334 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-04 |
| Decision Date | 2014-12-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852897002014 | K142490 | 000 |
| 00852897002007 | K142490 | 000 |