SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)


Device Classification Name

reamer

510(k) Number K111437
Device Name SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)
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 888.4540
Classification Product Code
HTO  
Subsequent Product Code
HRX  
Date Received 05/24/2011
Decision Date 08/10/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No