The following data is part of a premarket notification filed by Advanced Med/surg, Inc. with the FDA for Amsen Spine Impactor Instruments.
| Device ID | K921645 |
| 510k Number | K921645 |
| Device Name: | AMSEN SPINE IMPACTOR INSTRUMENTS |
| Classification | Orthopedic Manual Surgical Instrument |
| 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 | LXH |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-06 |
| Decision Date | 1992-06-03 |