The following data is part of a premarket notification filed by A.m. Surgical, Inc with the FDA for A.m. Surgical Intramedullary Fixation Device.
| Device ID | K180087 |
| 510k Number | K180087 |
| Device Name: | A.M. Surgical Intramedullary Fixation Device |
| Classification | Pin, Fixation, Smooth |
| Applicant | A.M. Surgical, Inc 222 Middle Country Road Suite 202 Smithtown, NY 11787 |
| Contact | Gavriel Feuer |
| Correspondent | Gavriel Feuer A.M. Surgical, Inc 222 Middle Country Road Suite 202 Smithtown, NY 11787 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-12 |
| Decision Date | 2018-05-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857915007125 | K180087 | 000 |
| 00857915007293 | K180087 | 000 |
| 00857915007309 | K180087 | 000 |
| 00857915007316 | K180087 | 000 |
| 00857915007323 | K180087 | 000 |
| 00857915007330 | K180087 | 000 |
| 00857915007347 | K180087 | 000 |
| 00857915007354 | K180087 | 000 |
| 00857915007361 | K180087 | 000 |
| 00857915007378 | K180087 | 000 |
| 00857915007385 | K180087 | 000 |
| 00857915007057 | K180087 | 000 |
| 00857915007064 | K180087 | 000 |
| 00857915007071 | K180087 | 000 |
| 00857915007088 | K180087 | 000 |
| 00857915007095 | K180087 | 000 |
| 00857915007286 | K180087 | 000 |