RECONSTRUCTION LOCKING PLATE AND 3.5MM LOCKING SCREW


Device Classification Name

plate, fixation, bone

510(k) Number K112819
Device Name RECONSTRUCTION LOCKING PLATE AND 3.5MM LOCKING SCREW
Applicant
XIAMEN DOUBLE ENGLINE MEDICAL MATERIAL CO., LTD
p.o. box 237-023
shanghai, 

CN

200237

Applicant Contact diana hong
Correspondent
XIAMEN DOUBLE ENGLINE MEDICAL MATERIAL CO., LTD
p.o. box 237-023
shanghai, 

CN

200237

Correspodent Contact diana hong
Regulation Number 888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received 09/28/2011
Decision Date 12/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No