Home / 510(k) Clearances / K033355

510(k) K033355

LACTOSCREW SCREW ANCHOR by Biomet Orthopedics, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2004
Date Received
October 20, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Biomet Orthopedics, Inc.

  • K243761 — A.L.P.S. Small Fragment Plating System (February 19, 2025)
  • K223631 — Comprehensive Segmental Revision System(SRS) (July 12, 2023)
  • K200196 — Taperloc® Complete Hip Stems (December 8, 2020)
  • K131393 — MAK OSS FEMORAL KNEE COMPONENTS (October 24, 2013)
  • K112905 — COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM (May 24, 2012)
  • K080528 — E-POLY TIBIAL BEARINGS (June 17, 2008)
  • K072879 — INNERVUE DIAGNOSTIC SCOPE SYSTEM (January 14, 2008)
  • K070955 — ACID ETCHED LAG SCREWS (October 12, 2007)
  • K032286 — CALCIGEN PSI BONE GRAFT SUBSTITUTE (November 20, 2003)
  • K030048 — HA PMI FEMORAL HIP STEM (February 5, 2003)

Other clearances for product code HWC

  • K260361 — Treace Medical Concepts (TMC) Screw Fixation System (March 6, 2026)
  • K252901 — Tyber Medical Trauma Screw (December 31, 2025)
  • K251555 — Ultra™ Compression Screw System (November 6, 2025)
  • K252312 — Eleganz IM Threaded Nail System (IM Threaded Nail System) (October 10, 2025)
  • K250536 — MetaFore Small Screw System (October 8, 2025)
  • K252758 — Cannulated Screw and Kirschner (K wire) System (October 2, 2025)
  • K252019 — CurvaFix Low Profile System (August 29, 2025)
  • K251382 — Phoenix Sinus Tarsi Stent System (August 27, 2025)
  • K250867 — Dunamis Screw and Suture Locking System (August 15, 2025)
  • K250251 — Eleganz Fusion Screw System (Fusion Screw System) (June 13, 2025)