The following data is part of a premarket notification filed by Axya Medical, Inc. with the FDA for Model 3000 Axyaloop Bio-absorbable Bone Anchor.
| Device ID | K051983 |
| 510k Number | K051983 |
| Device Name: | MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | AXYA MEDICAL, INC. 100 CUMMINGS CENTER SUITE 444C Beverly, MA 01915 |
| Contact | Howard Schrayer |
| Correspondent | Howard Schrayer AXYA MEDICAL, INC. 100 CUMMINGS CENTER SUITE 444C Beverly, MA 01915 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-22 |
| Decision Date | 2005-08-05 |
| Summary: | summary |