The following data is part of a premarket notification filed by Axya Medical, Inc. with the FDA for Axya Medical, Inc. Model 1000 Axyaloop Bone Anchor.
| Device ID | K003971 |
| 510k Number | K003971 |
| Device Name: | AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | AXYA MEDICAL, INC. 100 CUMMINGS CENTER SUITE 444C Beverly, MA 01915 |
| Contact | Howard L Schrayer |
| Correspondent | Howard L Schrayer AXYA MEDICAL, INC. 100 CUMMINGS CENTER SUITE 444C Beverly, MA 01915 |
| Product Code | MBI |
| Subsequent Product Code | GAS |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-22 |
| Decision Date | 2001-03-21 |