The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K972463 ↗

FDA Product Code

JEY

Device Class

Class II

Regulation

21 CFR Part 872.4760

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Kampner Hinged Toe Prosthesis

  Class II

  FDA 510(k) K801345 Active Cleared 8 Jul 1980

• The Bioplate Fixation System

  Class II

  FDA 510(k) K961976 Active Cleared 16 Aug 1996

• The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery

  Class II

  FDA 510(k) K992330 Active Cleared 23 Nov 1999

• The Titanium Fixation System

  Class II

  FDA 510(k) K943071 Active Cleared 6 Jan 1995

• Biomedics Bladder Scanner

  Class II

  FDA 510(k) K842687 Active Cleared 8 Apr 1985

• Bioplate Rigid Fixation Bone Plating System

  Class II

  FDA 510(k) K953273 Active Cleared 29 Sep 1995

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