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510(k) K173826

THP Hip Fracture Plating System by Biomet, Inc. — Product Code JDO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2018
Date Received
December 18, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Fixation, Proximal Femoral, Implant
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Biomet, Inc.

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  • K221968 — StageOne™ Shoulder Cement Spacer Molds (September 15, 2022)
  • K213287 — StageOne Knee Cement Spacer Molds (September 2, 2022)
  • K212431 — Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve (February 7, 2022)
  • K212435 — Comprehensive Humeral Fracture Positioning Sleeves (December 10, 2021)
  • K210192 — A.L.P.S. Clavicle Plating System (February 19, 2021)
  • K193214 — WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw Syste (November 10, 2020)
  • K193546 — Distal Centralizers (September 25, 2020)
  • K193373 — Comprehensive® Reverse Shoulder (April 15, 2020)

Other clearances for product code JDO

  • K230764 — OsteoCentric Integrated Hip Fastener System (April 18, 2023)
  • K213126 — Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, V (September 29, 2022)
  • K210247 — OsteoCentric Integrated Hip Fastener System (April 30, 2021)
  • K193029 — CONQUEST FN (February 28, 2020)
  • K172785 — CONQUEST FN (December 22, 2017)
  • K152686 — CONQUEST FN (March 17, 2016)
  • K140018 — TSP HIP FRACTURE PLATING SYSTEM (April 4, 2014)
  • K080685 — HIPLOC COMPRESSION HIP SCREW (August 15, 2008)
  • K080434 — INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW (April 10, 2008)
  • K983814 — GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM (January 14, 1999)