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FDA 510(k) Application Details - K023377
Device Classification Name
Appliance, Fixation, Spinal Intervertebral Body
More FDA Info for this Device
510(K) Number
K023377
Device Name
Appliance, Fixation, Spinal Intervertebral Body
Applicant
ORTHOTEC, L.L.C.
9595 WILSHIRE BLVD. SUITE 502
BEVERLY HILLS, CA 90212 US
Other 510(k) Applications for this Company
Contact
PATRICK BERTRANOU
Other 510(k) Applications for this Contact
Regulation Number
888.3060
More FDA Info for this Regulation Number
Classification Product Code
KWQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/08/2002
Decision Date
03/04/2003
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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