The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Ams Mainstay Urologic Bone Anchor.
| Device ID | K971332 |
| 510k Number | K971332 |
| Device Name: | AMS MAINSTAY UROLOGIC BONE ANCHOR |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Contact | John M Otto |
| Correspondent | John M Otto AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-10 |
| Decision Date | 1997-07-09 |
| Summary: | summary |