INION HEXALON BIODEGRADABLE ACL/PCL SCREW


Device Classification Name

screw, fixation, bone

510(k) Number K021280
Device Name INION HEXALON BIODEGRADABLE ACL/PCL SCREW
Original Applicant
INION LTD.
laakarinkatu 2
tampere, 

FI

fin-33520

Original Contact hanna marttila
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 04/22/2002
Decision Date 07/17/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No