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FDA 510(k) Application Details - K021379
Device Classification Name
Orthosis, Spinal Pedicle Fixation
More FDA Info for this Device
510(K) Number
K021379
Device Name
Orthosis, Spinal Pedicle Fixation
Applicant
ORTHO TEC LLC
8202 SHERMAN RD.
CHESTERLAND, OH 44026-2141 US
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Contact
KAREN E WARDEN
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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
05/01/2002
Decision Date
05/31/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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