Osteo Femoral Nail

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

510(k) Number

K922195 ↗

FDA Product Code

HSB

Device Class

Class II

Regulation

21 CFR Part 888.3020

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Osteo Ex-Fi-Re

  Class II

  FDA 510(k) K920149 Active Cleared 9 Apr 1992

• Osteo Kirschner Wire

  Class II

  FDA 510(k) K922193 Active Cleared 23 Jul 1992

• Osteo Compression Hip Screw

  Class II

  FDA 510(k) K920037 Active Cleared 11 Mar 1992

• Osteo Interlocking-Compression Nail

  Class II

  FDA 510(k) K933340 Active Cleared 30 Jun 1994

• Osteo Complete Pneumatic Drill-Oscilair

  Class I

  FDA 510(k) K913559 Active Cleared 7 Nov 1991

• Osteo Cerclage Wire

  Class II

  FDA 510(k) K914374 Active Cleared 30 Dec 1991

See all devices from Osteo AG →

• What is the primary clinical application of the Osteo Femoral Nail?

  This device is specifically designed for the fixation of femoral fractures. It is utilized by surgeons in orthopedic procedures to provide necessary stabilization to bone segments after a patient has experienced high-energy trauma.

• What is the regulatory status of this femoral nail?

  The Osteo Femoral Nail has received FDA 510(k) clearance. This indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices within the orthopedic product category.

• How is this device categorized for regulatory purposes?

  The device is categorized under product code HSB, which is designated for orthopedic applications. This classification is used to identify the specific regulatory pathway and advisory committee oversight for the device.