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FDA 510(k) Application Details - K003823
Device Classification Name
Appliance, Fixation, Spinal Interlaminal
More FDA Info for this Device
510(K) Number
K003823
Device Name
Appliance, Fixation, Spinal Interlaminal
Applicant
ORTHOTEC, L.L.C.
546 HILLGREEN DR.
BEVERLY HILLS, CA 90212-4110 US
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Contact
PATRICK BERTRANOU
Other 510(k) Applications for this Contact
Regulation Number
888.3050
More FDA Info for this Regulation Number
Classification Product Code
KWP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/11/2000
Decision Date
07/11/2001
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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