The following data is part of a premarket notification filed by A.m. Surgical, Inc. with the FDA for A.m. Surgical Cpf Distal Radial External Cross Pin Fixation System.
| Device ID | K042458 |
| 510k Number | K042458 |
| Device Name: | A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
| Applicant | A.M. SURGICAL, INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Carolann Kotula |
| Correspondent | Carolann Kotula A.M. SURGICAL, INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | LXT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-10 |
| Decision Date | 2004-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857915007019 | K042458 | 000 |
| 00857915007002 | K042458 | 000 |
| 00857915007606 | K042458 | 000 |