TiMesh Self Drilling Screw

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

510(k) Number

K062348 ↗

FDA Product Code

HWC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Medtronic Neurosurgery →

• What is the TiMesh Self Drilling Screw used for?

  The TiMesh Self Drilling Screw is designed for orthopedic applications and is part of the TiMesh System. It is not intended for spinal use and utilizes materials and technology from previously reviewed and cleared systems.

• Is the TiMesh Self Drilling Screw reusable or single-use?

  The TiMesh Self Drilling Screw is supplied as a single-use product and should not be reused for patient safety and regulatory compliance purposes.

• What sizes are available for the TiMesh Self Drilling Screw?

  The TiMesh Self Drilling Screw is available in various sizes, including a 1.5mm version with a cruciate, self-tapping shaft designed for specific orthopedic applications.

• What regulatory clearance has the TiMesh Self Drilling Screw received?

  The TiMesh Self Drilling Screw has received FDA 510(k) clearance with number K062348 and is classified under product code HWC. It was determined to be substantially equivalent to predicate devices.