BIOSTEON CROSS PIN


Device Classification Name

screw, fixation, bone

510(k) Number K021351
Device Name BIOSTEON CROSS PIN
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 04/29/2002
Decision Date 10/17/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls