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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthosis, spinal pedicle fixation
510(k) Number K040493
Device Name OUTOLOGOUS SPINAL FIXATION SYSTEM
Applicant
ORTHOPEDIC SCIENCES, INC
4329 GRAYDON RD.
SAN DIEGO,  CA  92130
Applicant Contact FLOYD G LARSON
Correspondent
ORTHOPEDIC SCIENCES, INC
4329 GRAYDON RD.
SAN DIEGO,  CA  92130
Correspondent Contact FLOYD G LARSON
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received02/26/2004
Decision Date 09/03/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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