STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLATE TITANIUM FIXATION SYSTEM


Device Classification Name

plate, bone

510(k) Number K022033
Device Name STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLATE TITANIUM FIXATION SYSTEM
Original Applicant
BIOPLATE, INC.
815 connecticut ave nw
washington, 
DC 
20006 -4004

Original Contact bruce f mackler
Regulation Number 872.4760
Classification Product Code
JEY  
Date Received 06/21/2002
Decision Date 07/19/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized