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FDA 510(k) Application Details - K022374
Device Classification Name
Appliance, Fixation, Spinal Interlaminal
More FDA Info for this Device
510(K) Number
K022374
Device Name
Appliance, Fixation, Spinal Interlaminal
Applicant
SULZER SPINE-TECH
7375 BUSH LAKE RD.
MINNEAPOLIS, MN 55439-2027 US
Other 510(k) Applications for this Company
Contact
KRISTYN M BENSON
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
07/22/2002
Decision Date
09/24/2002
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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