SHORT LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT MODEL 3017-000 (LEFT) AND 3018-000 (RIGHT); 6 HOLE MEDIUM MIDSHAFT


Device Classification Name

plate, fixation, bone

510(k) Number K122623
Device Name SHORT LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT MODEL 3017-000 (LEFT) AND 3018-000 (RIGHT); 6 HOLE MEDIUM MIDSHAFT
Applicant
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
386 beech avenue
unit b6
torrance, 
CA 
90501

Applicant Contact allyson parks
Correspondent
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
386 beech avenue
unit b6
torrance, 
CA 
90501

Correspodent Contact allyson parks
Regulation Number 888.3030
Classification Product Code
HRS  
Date Received 08/28/2012
Decision Date 09/26/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No