Sintea Biotech PLS Multi-Axial Screws, Model PLS.XX.T5.X

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

510(k) Number

K060513 ↗

FDA Product Code

KWP

Device Class

Class II

Regulation

21 CFR Part 888.3050

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Sintea Biotech Dsc/Alf Spinal System, DSC.XX.T5.XX, ALF.XX.T5.XX

  Class II

  FDA 510(k) K070181 Active Cleared 18 Apr 2007

• Sintea Biotech Posterior Lumbar System with Polyaxial and Recovery Screws, Model PLS.01.T5.X

  Class II

  FDA 510(k) K043355 Active Cleared 17 Dec 2004

• Traumafix System, Model TFX.00.00.X

  Class II

  FDA 510(k) K022065 Active Cleared 6 Aug 2002

• Sintea Biotech Posterior Lumbar System, Model Pls 00.T5.X

  Class II

  FDA 510(k) K020085 Active Cleared 10 Dec 2002

• Sintea Biotech Anterior Plate System, Model ACP.XX.T5.X

  Class II

  FDA 510(k) K041989 Active Cleared 16 Sep 2004

• X-Void, Spider

  Class II

  FDA 510(k) K072198 Active Cleared 6 Jun 2008

See all devices from Sintea Biotech, Inc. →

• What is the Sintea Biotech PLS Multi-Axial Screws system used for?

  The Sintea Biotech Posterior Lumbar System Sunflower II is a multi-axial pedicle screw system used by spinal surgeons to provide spinal stabilization and immobilization as an adjunct to fusion for treating spinal instabilities or deformities, specifically indicated for degenerative disc disease in the noncervical spine.

• How is the Sintea Biotech PLS Multi-Axial Screws system supplied?

  The system is supplied as a sterile, single-use system and requires appropriate storage conditions. It includes multi-axial screws and associated hardware necessary for posterior spinal stabilization procedures.

• What is the regulatory status of the Sintea Biotech PLS Multi-Axial Screws system?

  The Sintea Biotech PLS Multi-Axial Screws, Model PLS.XX.T5.X, has received FDA 510(k) clearance with the K number K060513. It was determined to be substantially equivalent to predicate devices for its intended use in spinal stabilization.

• What components are included in the Sintea Biotech PLS Multi-Axial Screws system?

  The system consists of multi-axial screws and associated hardware designed for posterior spinal fixation. It is specifically engineered for non-pedicle screw applications in the noncervical spine, with the model number PLS.XX.T5.X identifying this specific configuration.