Spine Fixation

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K943827 ↗

FDA Product Code

MNH

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SN

• Modification of Tsrh Spinal System

  Class II

  FDA 510(k) K984522 Active Cleared 6 Jan 1999

• Overhead Arm Slings

  Class I

  FDA 510(k) K823811 Active Cleared 14 Jan 1983

• Cd Horizon Spinal System

  Class II

  FDA 510(k) K993810 Active Cleared 3 Feb 2000

• Danek Precision Rod Set

  Class II

  FDA 510(k) K896254 Active Cleared 14 Jun 1990

• Modification of the Zplate-Atl Anterior Fixation System

  Class II

  FDA 510(k) K990603 Active Cleared 10 Mar 1999

• Danek Spinalscope

  Class II

  FDA 510(k) K901692 Active Cleared 14 Feb 1992

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