The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Stapletac2 Bone Anchor System.
| Device ID | K000279 |
| 510k Number | K000279 |
| Device Name: | STAPLETAC2 BONE ANCHOR SYSTEM |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Contact | Sylvia L Gubbe |
| Correspondent | Sylvia L Gubbe AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-31 |
| Decision Date | 2000-03-01 |