BIOLOK SCREW


Device Classification Name

screw, fixation, bone

510(k) Number K002070
Device Name BIOLOK SCREW
Original Applicant
BIOCOMPOSITES LTD.
etruscan st., etruria
stoke on trent, 

GB

st1 5pq

Original Contact j.stephen bratt
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 07/07/2000
Decision Date 08/25/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No