The following data is part of a premarket notification filed by A.m. Surgical, Inc. with the FDA for Secure Screw.
| Device ID | K191771 |
| 510k Number | K191771 |
| Device Name: | SECURE Screw |
| Classification | Screw, Fixation, Bone |
| Applicant | A.M. Surgical, Inc. 285 Middle Country Road, Suite 206 Smithtown, NY 11787 |
| Contact | Vincent Pascale |
| Correspondent | Vincent Pascale A.M. Surgical, Inc. 285 Middle Country Road, Suite 206 Smithtown, NY 11787 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-02 |
| Decision Date | 2019-10-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10857915007566 | K191771 | 000 |
| 00857915007262 | K191771 | 000 |
| 10857915007238 | K191771 | 000 |
| 00857915007255 | K191771 | 000 |
| 10857915007214 | K191771 | 000 |
| 00857915007248 | K191771 | 000 |
| 10857915007191 | K191771 | 000 |