Radius Osteotomy Plates

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

510(k) Number

K914804 ↗

FDA Product Code

HRS

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SN

• Link Cortical Screws

  Class II

  FDA 510(k) K854827 Active Cleared 27 Dec 1985

• Link Contour Ribbed Hip Prostheses System

  Class II

  FDA 510(k) K854465 Active Cleared 10 Feb 1986

• Link Ceramic Heads 12/14 X 32mm

  Class II

  FDA 510(k) K931571 Active Cleared 19 Apr 1994

• Schwabe Radius Plates

  Class II

  FDA 510(k) K914803 Active Cleared 28 Apr 1992

• Link Dynamic Staple

  Class II

  FDA 510(k) K853704 Active Cleared 21 Jan 1986

• Feldmuhle Ceramic Head

  Class II

  FDA 510(k) K920756 Active Cleared 18 May 1992

See all devices from Link America, Inc. →

• What is the primary clinical purpose of the Radius Osteotomy Plates?

  These plates are orthopedic devices specifically designed for surgical procedures involving the radius bone. They function to stabilize and fixate the bone during an osteotomy to ensure proper alignment and support the healing process.

• What is the regulatory status of these osteotomy plates?

  The Radius Osteotomy Plates are authorized under FDA 510(k) clearance number K914804. This clearance indicates that the device has been reviewed and determined to be substantially equivalent for certain indications.

• Who is the manufacturer of the Radius Osteotomy Plates?

  The Radius Osteotomy Plates are manufactured by Link America, Inc., located in East Hanavor, New Jersey. The company is registered under the orthopedic advisory committee for this device.