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510(k) K212431

Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve by Biomet, Inc. — Product Code JDG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2022
Date Received
August 4, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Femoral Component, Cemented, Metal
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type

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  • K213287 — StageOne Knee Cement Spacer Molds (September 2, 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)
  • K193402 — ALLthread PEEK Suture Anchor (March 5, 2020)

Other clearances for product code JDG

  • K193546 — Distal Centralizers (September 25, 2020)
  • K173499 — Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads (March 19, 2018)
  • K001984 — PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT (September 27, 2000)
  • K992234 — THE TAPER-FIT TOTAL HIP SYSTEM (November 10, 1999)
  • K962002 — AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM (August 8, 1996)
  • K955171 — NEXLOCK FEMORAL STEM (February 9, 1996)
  • K953653 — LUBINUS SP II HIP SYSTEM (November 6, 1995)
  • K953067 — HIP FRACTURE STEM FENESTRATION PLUG (August 21, 1995)
  • K945783 — ORTHOMET TITANIUM HYBRID FEMORAL STEM (May 30, 1995)
  • K951083 — PROFORM CEMENTED FEMORAL COMPONENT (May 22, 1995)