MICOMED POSTERIOR DOUBLEROD SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K021275
Device Name MICOMED POSTERIOR DOUBLEROD SYSTEM
Original Applicant
MICOMED ORTHO GMBH
22086 elsberry way
lake forest, 
CA 
92630

Original Contact corrine m taflinger
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Code
KWP  
Date Received 04/22/2002
Decision Date 07/18/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No