SYNTHES LCP PEDIATRIC PLATE SYSTEMS


Device Classification Name

plate, fixation, bone

510(k) Number K112085
Device Name SYNTHES LCP PEDIATRIC PLATE SYSTEMS
Applicant
SYNTHES (USA) PRODUCTS LLC
1301 goshen pkwy.
west chester, 
PA 
19380

Applicant Contact angela f lassandro
Correspondent
SYNTHES (USA) PRODUCTS LLC
1301 goshen pkwy.
west chester, 
PA 
19380

Correspodent Contact angela f lassandro
Regulation Number 888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received 07/21/2011
Decision Date 11/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No