Fx-Cablelok System, Modification

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K915259 ↗

FDA Product Code

JDQ

Device Class

Class II

Regulation

21 CFR Part 888.3010

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• EZ-FIX Small Cannulated Screw System

  Class II

  FDA 510(k) K962987 Active Cleared 4 Nov 1996

• Shoulder-Holder

  Not classified

  FDA 510(k) K851206 Active Cleared 25 Apr 1985

• Universal Power Flex

  Class I

  FDA 510(k) K851177 Active Cleared 28 Jun 1985

• Biodynamics Femoral Canal Brush #1201

  Class I

  FDA 510(k) K870349 Active Cleared 13 Feb 1987

• Universal Bone Cement Kit

  Class II

  FDA 510(k) K931540 Active Cleared 27 Jan 1994

• Anatomic Proportional Shoulder APS (Hemi-Shoulder) System

  Class II

  FDA 510(k) K935593 Active Cleared 14 Oct 1994

See all devices from Biodynamic Technologies, Inc. →