Model 3000 Axyzloop Titanium Bone Anchor
by Axya Medical, Inc. 510(k)
Active
510(k) K070773
Overview
The Model 3000 Axyzloop Titanium Bone Anchor is a titanium orthopedic device designed for securing soft tissue to bone. Its corkscrew-style thread facilitates stable fixation during extremity repairs, providing a reliable attachment point for surgical reconstruction.
This device is supplied as a system, including the anchor, drill bit, delivery/extraction handle, and drill guide. Pre-threaded with size 2/0 USP non-absorbable monofilament suture, it is intended for single-use and has received FDA 510(k) clearance under K070773 for orthopedic applications. Sterility and regulatory compliance are ensured through the manufacturer’s validated processes.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK070773 | Date11 Oct 2007 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Axya, Model 3000 Axyzloop Titanium Bone Anchor
- 510(k) Number
- FDA Product Code
- MBI
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3040
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent