TSRH Central Post Hooks

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

510(k) Number

K925811 ↗

FDA Product Code

KWP

Device Class

Class II

Regulation

21 CFR Part 888.3050

Advisory Committee

Orthopedic

FDA Decision

SN

• Z-Plate Anterior Fixation System

  Class II

  FDA 510(k) K922543 Active Cleared 19 May 1993

• Titanium Alloy Songer Cable System

  Class II

  FDA 510(k) K920201 Active Cleared 8 Apr 1992

• Titanium Songer Cable System

  Class II

  FDA 510(k) K925812 Active Cleared 24 Mar 1993

• Sentry Posterior Spinal System

  Class II

  FDA 510(k) K930710 Active Cleared 1 Oct 1993

• Resorabplug

  Class II

  FDA 510(k) K920118 Active Cleared 8 Feb 1993

• Reconstruction Plate System

  Class II

  FDA 510(k) K924085 Active Cleared 17 Dec 1992

See all devices from Sofamor Danek Mfg., Inc. →

• Are these TSRH Central Post Hooks meant for repeated use in multiple patients, or are they designed for single-patient use only?

  These TSRH Central Post Hooks are explicitly classified as single-use devices. They are supplied sterile and intended for one-time use during a single surgical procedure to ensure patient safety and infection control.

• What types of spinal procedures are these hooks intended to support, and how do they function in those applications?

  The TSRH Central Post Hooks are designed for spinal stabilization procedures, specifically for secure anchoring to the vertebral body within a spinal fixation system. They attach to the central portion of the spine, providing structural support during orthopedic surgeries where spinal alignment or stabilization is required.

• How are these hooks supplied, and what should clinicians expect when receiving their order?

  The TSRH Central Post Hooks are supplied sterile, ready for immediate use in the operating room. Since they are single-use, each package is intended for one surgical procedure, ensuring no reprocessing or reuse is necessary.

• What regulatory pathway does this device follow, and how does that affect its use in clinical settings?

  These hooks follow the FDA 510(k) regulatory pathway, with clearance number K925811 under product code KWP. This means they have been determined to be substantially equivalent to a legally marketed device for some indications, ensuring they meet FDA standards for safety and effectiveness in spinal fixation applications.