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510(k) K082175

MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION by Bioplate, Inc. — Product Code GXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2008
Date Received
August 1, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Cranioplasty, Preformed, Non-Alterable
Device Class
Class II
Regulation Number
882.5330
Review Panel
NE
Submission Type

Other clearances by Bioplate, Inc.

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  • 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)
  • K022890 — MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION BONE PLATING SYS (September 6, 2002)

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