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Model 3000 Axyaloop Bio-Absorbable Bone Anchor

by Axya Medical, Inc. 510(k)

Active United States

510(k) K051983

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK051983 Date5 Aug 2005ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

21 recalls · FDA

  • 21 recalls, same reason

    • Terminated Z-0355-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K051983, on the same 510(k)
    • Terminated Z-0337-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K051983, on the same 510(k)
    • Terminated Z-0334-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K051983, on the same 510(k)
    • Terminated Z-0333-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K051983, on the same 510(k)
    • Terminated Z-0344-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K051983, on the same 510(k)
    • Terminated Z-0332-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K051983, on the same 510(k)
    • Terminated Z-0348-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K051983, on the same 510(k)
    • Terminated Z-0354-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K051983, on the same 510(k)
    • Terminated Z-0350-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K051983, on the same 510(k)
    • Terminated Z-0346-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K051983, on the same 510(k)
    • Terminated Z-0343-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K051983, on the same 510(k)
    • Terminated Z-0352-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K051983, on the same 510(k)
    • Terminated Z-0335-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K051983, on the same 510(k)
    • Terminated Z-0339-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K051983, on the same 510(k)
    • Terminated Z-0351-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K051983, on the same 510(k)
    • Terminated Z-0341-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K051983, on the same 510(k)
    • Terminated Z-0349-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K051983, on the same 510(k)
    • Terminated Z-0353-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K051983, on the same 510(k)
    • Terminated Z-0342-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K051983, on the same 510(k)
    • Terminated Z-0347-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K051983, on the same 510(k)
    • Terminated Z-0331-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K051983, on the same 510(k)

    Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
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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