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510(k) K022986

THE BIOPLATE BATTERY POWERED DRILL by Bioplate, Inc. — Product Code HBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2002
Date Received
September 9, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Drill, Electric
Device Class
Class II
Regulation Number
882.4360
Review Panel
NE
Submission Type

Other clearances by Bioplate, Inc.

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  • K082175 — MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION (August 13, 2008)
  • 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)
  • K022890 — MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION BONE PLATING SYS (September 6, 2002)

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