INION OTPS BIODEGRADABLE MINI PLATING SYSTEM


Device Classification Name

screw, fixation, bone

510(k) Number K023887
Device Name INION OTPS BIODEGRADABLE MINI PLATING SYSTEM
Original Applicant
INION LTD.
laakarinkatu 2
tampere, 

FI

33520

Original Contact hanna marttila
Regulation Number 888.3040
Classification Product Code
HWC  
Subsequent Product Code
HRS  
Date Received 11/21/2002
Decision Date 05/30/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No