Link Small Bone Plates

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

510(k) Number

K854825 ↗

FDA Product Code

HRS

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• 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

• Radius Osteotomy Plates

  Class II

  FDA 510(k) K914804 Active Cleared 29 Apr 1992

• Link Dynamic Staple

  Class II

  FDA 510(k) K853704 Active Cleared 21 Jan 1986

See all devices from Link America, Inc. →

• What are Link Small Bone Plates used for?

  Link Small Bone Plates are orthopedic fixation devices designed to provide support and alignment for small bone fractures or repairs during surgical procedures.

• How are Link Small Bone Plates supplied?

  The device is supplied as a sterile, single-use implant and is available in various sizes to accommodate different anatomical requirements.

• What is the regulatory classification of Link Small Bone Plates?

  Link Small Bone Plates are classified as a Class II medical device under product code HRS and received FDA 510(k) clearance on January 21, 1986, with a determination of substantial equivalence.

• Can Link Small Bone Plates be reused?

  No, Link Small Bone Plates are designed as single-use implants and should not be reused to ensure patient safety and device integrity.