The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Anatoemic Phalangeal Prosthesis.
| Device ID | K063058 |
| 510k Number | K063058 |
| Device Name: | ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS |
| Classification | Prosthesis, Toe, Hemi-, Phalangeal |
| Applicant | ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Contact | Nancy Hoft |
| Correspondent | Nancy Hoft ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Product Code | KWD |
| CFR Regulation Number | 888.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-05 |
| Decision Date | 2007-01-03 |
| Summary: | summary |