The following data is part of a premarket notification filed by Medcanica, Inc. with the FDA for Phalangeal Fixation System.
| Device ID | K994232 |
| 510k Number | K994232 |
| Device Name: | PHALANGEAL FIXATION SYSTEM |
| Classification | Pin, Fixation, Smooth |
| Applicant | MEDCANICA, INC. 19526 EAST LAKE DR. Miami, FL 33015 |
| Contact | Al Weisenborn |
| Correspondent | Al Weisenborn MEDCANICA, INC. 19526 EAST LAKE DR. Miami, FL 33015 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-16 |
| Decision Date | 2000-03-01 |
| Summary: | summary |