BIOACTIF OSTEOTRANS INTERFENCE SCREW


Device Classification Name

screw, fixation, bone

510(k) Number K081390
Device Name BIOACTIF OSTEOTRANS INTERFENCE SCREW
Applicant
TAKIRON CO., LTD
7-1-19, minatojimaminamimachi,
chuo-ku
kobe, hyogo, 

JP

650-0047

Applicant Contact kunihiro hata
Correspondent
TAKIRON CO., LTD
7-1-19, minatojimaminamimachi,
chuo-ku
kobe, hyogo, 

JP

650-0047

Correspodent Contact kunihiro hata
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 05/19/2008
Decision Date 08/12/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No