The following data is part of a premarket notification filed by Axya Medical, Inc. with the FDA for Axya Model 6500 Axyaloop Self-tapping Bone Anchor.
| Device ID | K052491 |
| 510k Number | K052491 |
| Device Name: | AXYA MODEL 6500 AXYALOOP SELF-TAPPING 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 |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-12 |
| Decision Date | 2005-10-07 |
| Summary: | summary |