BONE PLATE; BONE SCREW


Device Classification Name

plate, bone

510(k) Number K110926
Device Name BONE PLATE; BONE SCREW
Applicant
BIOMATERIALS KOREA INC.
5401 s. cottonwood ct.
greenwood village, 
CO 
80121

Applicant Contact kevin walls
Correspondent
BIOMATERIALS KOREA INC.
5401 s. cottonwood ct.
greenwood village, 
CO 
80121

Correspodent Contact kevin walls
Regulation Number 872.4760
Classification Product Code
JEY  
Date Received 04/01/2011
Decision Date 12/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No