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510(k) K021684

THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY by Bioplate, Inc. — Product Code JEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2002
Date Received
May 22, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Bone
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type

Other clearances by Bioplate, Inc.

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  • K070901 — MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM (June 15, 2007)
  • K062819 — BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY (December 4, 2006)
  • K051845 — THE BIOPLATE RESORBABLE ENDOBROW FIXATION SYSTEM (July 27, 2005)
  • K031028 — THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY (April 28, 2003)
  • K030806 — BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY (April 8, 2003)
  • K023810 — MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFAC (December 4, 2002)
  • K023665 — MODIFICATION TO BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGE (November 22, 2002)
  • K022986 — THE BIOPLATE BATTERY POWERED DRILL (November 19, 2002)

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