ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES


Device Classification Name

plate, bone

510(k) Number K072528
Device Name ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES
Applicant
PROSURG, INC.
2193 trade zone blvd.
san jose, 
CA 
95131

Applicant Contact ashvin desai
Correspondent
PROSURG, INC.
2193 trade zone blvd.
san jose, 
CA 
95131

Correspodent Contact ashvin desai
Regulation Number 872.4760
Classification Product Code
JEY  
Date Received 09/07/2007
Decision Date 12/28/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No