Axya, Model 6500 Axyaloop Bio-Absorbable Bone Anchor

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K051250 ↗

FDA Product Code

MAI

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K011912 Active Cleared 31 Aug 2001

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  FDA 510(k) K041698 Active Cleared 5 Oct 2004

• Axya Medical, Inc. Model 1000 Axyaloop Bone Anchor

  Class II

  FDA 510(k) K003971 Active Cleared 21 Mar 2001

See all devices from Axya Medical, Inc. →