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FDA 510(k) Application Details - K081240
Device Classification Name
Arthroscope
More FDA Info for this Device
510(K) Number
K081240
Device Name
Arthroscope
Applicant
SPINAL DEVICES, LLC
13540 GUILD AVE
APPLE VALLEY, MN 55124 US
Other 510(k) Applications for this Company
Contact
RICHARD JANSEN
Other 510(k) Applications for this Contact
Regulation Number
888.1100
More FDA Info for this Regulation Number
Classification Product Code
HRX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/01/2008
Decision Date
02/27/2009
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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