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FDA 510(k) Application Details - K021275
Device Classification Name
Orthosis, Spinal Pedicle Fixation
More FDA Info for this Device
510(K) Number
K021275
Device Name
Orthosis, Spinal Pedicle Fixation
Applicant
MICOMED ORTHO GMBH
22086 ELSBERRY WAY
LAKE FOREST, CA 92630 US
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Contact
CORRINE M TAFLINGER
Other 510(k) Applications for this Contact
Regulation Number
888.3070
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Classification Product Code
MNI
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More FDA Info for this Product Code
Date Received
04/22/2002
Decision Date
07/18/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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