Suture Welding System and Kit (Swk)

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K983108 ↗

FDA Product Code

GAW

Device Class

Class II

Regulation

21 CFR Part 878.5010

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Model 2000 Axyaloop Self-Tapping Bone Anchor, Model 2000

  Class II

  FDA 510(k) K011912 Active Cleared 31 Aug 2001

• Axyaflex Polyester Suture

  Class II

  FDA 510(k) K060165 Active Cleared 1 Sep 2006

• Axya, Model 6500 Axyaloop Bio-Absorbable Bone Anchor

  Class II

  FDA 510(k) K051250 Active Cleared 9 Jun 2005

• AxyaLoop Nonabsorbable Bone Anchor

  Class II

  FDA 510(k) K060970 Active Cleared 5 Jul 2006

• Axya Medical Inc, Bone Anchor System and Kit- (Bak)

  Class II

  FDA 510(k) K992405 Active Cleared 22 Sep 1999

• Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone Anchor

  Class II

  FDA 510(k) K041698 Active Cleared 5 Oct 2004

See all devices from Axya Medical, Inc. →