Orthopedic Plate System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K972219 ↗

FDA Product Code

HRS

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• DICOM Theater

  Class II

  FDA 510(k) K033153 Active Cleared 23 Apr 2004

• Targobeam

  Class II

  FDA 510(k) K970819 Active Cleared 14 Jul 1997

• Airox Axr. 1A

  Class II

  FDA 510(k) K901953 Active Cleared 2 Jan 1991

• Fixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of Unstable Femoral Neck Fractures

  Class II

  FDA 510(k) K970258 Active Cleared 22 May 1997

• Cart, Multipurpose

  Not classified

  FDA 510(k) K880539 Active Cleared 24 Feb 1988

• Dp 100

  Class II

  FDA 510(k) K911192 Active Cleared 11 Dec 1991

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