Titanium Gdlh Posterior Spinal System

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

510(k) Number

K954645 ↗

FDA Product Code

KWP

FDA applicant

Sofamor Danek USA,Inc.

Device Class

Class II

Regulation

21 CFR Part 888.3050

Advisory Committee

Orthopedic

FDA Decision

SN

• Tsrh Spinal System

  Class II

  FDA 510(k) K982990 Active Cleared 21 Oct 1998

• Paragon Posterior Spinal System

  Class II

  FDA 510(k) K950955 Active Cleared 25 Aug 1995

• Orion Anterior Cervical Plate System

  Class II

  FDA 510(k) K973854 Active Cleared 16 Mar 1998

• Titanium Tsrh(R) Spinal System (Screws)

  Class II

  FDA 510(k) K946348 Active Cleared 7 Aug 1995

• Incl Endoscope

  Class II

  FDA 510(k) K955471 Active Cleared 18 Dec 1995

• Acpii Anterior Cervical Plate System

  Class II

  FDA 510(k) K970806 Active Cleared 2 May 1997

See all devices from Sofamor Danek USA, Inc. →