Smooth or Threaded Metallic Bone Fastener

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K131640 ↗

FDA Product Code

HTY

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Hammerlock

  Class II

  FDA 510(k) K091951 Active Cleared 19 Feb 2010

• Bone and Marrow Collection System Kit

  Class I

  FDA 510(k) K971782 Active Cleared 29 Jul 1997

• Osstaple Chill

  Class II

  FDA 510(k) K102107 Active Cleared 3 Sep 2010

• Memograph; Osstaple - Oral and Maxilliofacial Procedures for the Memograph Staple System

  Class II

  FDA 510(k) K001219 Active Cleared 21 Jun 2000

• Memograph Staple, Warm System

  Class II

  FDA 510(k) K993714 Active Cleared 25 Feb 2000

• Bme Bone Drill Bits

  Class I

  FDA 510(k) K964073 Active Cleared 14 Nov 1996

See all devices from Biomedical Ent., Inc. →