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FDA 510(k) Application Details - K002069
Device Classification Name
Appliance, Fixation, Spinal Interlaminal
More FDA Info for this Device
510(K) Number
K002069
Device Name
Appliance, Fixation, Spinal Interlaminal
Applicant
SPINAL INNOVATIONS, LLC.
7850 STAGE HILLS BLVD.
SUITE 105
BARTLETT, TN 38133 US
Other 510(k) Applications for this Company
Contact
KEN RUSSELL
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
07/07/2000
Decision Date
10/05/2000
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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