LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; MIDSHAFT SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; ANTERIOR CLAVICLE PLA


Device Classification Name

plate, fixation, bone

510(k) Number K103513
Device Name LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; MIDSHAFT SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; ANTERIOR CLAVICLE PLA
Applicant
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
386 beech avenue
unit b6
torrance, 
CA 
90501

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

Correspodent Contact julie glendrange
Regulation Number 888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received 11/30/2010
Decision Date 10/24/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No