TSRH Open Head Bone Screw

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K911319 ↗

FDA Product Code

KWP

Device Class

Class II

Regulation

21 CFR Part 888.3050

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• 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

• Spine Fixation

  Class II

  FDA 510(k) K943827 Active Cleared 14 Feb 1996

• Modification of the Zplate-Atl Anterior Fixation System

  Class II

  FDA 510(k) K990603 Active Cleared 10 Mar 1999

See all devices from Danek Medical, Inc. →

• What is the TSRH Open Head Bone Screw used for?

  The TSRH Open Head Bone Screw is an orthopedic device designed to provide stabilization in skeletal structures during surgical procedures. It helps maintain proper alignment and support of bones during recovery.

• Is the TSRH Open Head Bone Screw reusable or single-use?

  The TSRH Open Head Bone Screw is intended for single-use applications only. After being used in a surgical procedure, it should not be reused to ensure patient safety and device effectiveness.

• What regulatory approvals does the TSRH Open Head Bone Screw have?

  The TSRH Open Head Bone Screw received FDA 510(k) clearance on September 6, 1991, with product code KWP and model number K911319. It was determined to be substantially equivalent to other marketed devices.

• Who manufactures the TSRH Open Head Bone Screw?

  The TSRH Open Head Bone Screw is manufactured by Danek Medical, Inc., located in Memphis, Tennessee. The company is responsible for supplying this orthopedic fixation device for surgical use.