SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS


Device Classification Name

rod, fixation, intramedullary and accessories

510(k) Number K111891
Device Name SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS
Applicant
SYNTHES (USA) PRODUCTS LLC
1303 goshen parkway
west chester, 
PA 
19380

Applicant Contact christopher hack
Correspondent
SYNTHES (USA) PRODUCTS LLC
1303 goshen parkway
west chester, 
PA 
19380

Correspodent Contact christopher hack
Regulation Number 888.3020
Classification Product Code
HSB  
Subsequent Product Codes
HRS   KTT  
Date Received 07/05/2011
Decision Date 11/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No