The following data is part of a premarket notification filed by Advanced Med/surg, Inc. with the FDA for Amset(tm) Bone Screw.
| Device ID | K911768 |
| 510k Number | K911768 |
| Device Name: | AMSET(TM) BONE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | ADVANCED MED/SURG, INC. 25590 SEABOARD LN. Hayward, CA 94545 |
| Contact | Ronald C Allen |
| Correspondent | Ronald C Allen ADVANCED MED/SURG, INC. 25590 SEABOARD LN. Hayward, CA 94545 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-19 |
| Decision Date | 1991-10-04 |