Smartscrew II, Models 232010, 232012, 232014, 232016, 232018, 232020

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

510(k) Number

K042295 ↗

FDA Product Code

HWC

Models / Variants

232010

232012

232014

232016

232018

232020

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Modification to Smartpin

  Class II

  FDA 510(k) K041288 Active Cleared 10 Jun 2004

• Biosorb Fx and Biosorb Pdx 1.5 and 2.0 Screws

  Class II

  FDA 510(k) K042517 Active Cleared 8 Oct 2004

• 2.4 Smartnail, Models 532416, 532425, 532435, 532445

  Class II

  FDA 510(k) K031981 Active Cleared 25 Jul 2003

• Cannulated Nugen Fx Screw Fully Threaded, Cannulated Nugen Fx Screw Partially Threaded

  Class II

  FDA 510(k) K032447 Active Cleared 16 Apr 2004

• Matryx Interference Screw

  Class II

  FDA 510(k) K052080 Active Cleared 25 Aug 2005

• Osteo Acl Screw MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T,

  Class II

  FDA 510(k) K032894 Active Cleared 7 May 2004

See all devices from Linvatec Biomaterials, Ltd. →