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FDA 510(k) Application Details - K091159
Device Classification Name
Appliance, Fixation, Spinal Intervertebral Body
More FDA Info for this Device
510(K) Number
K091159
Device Name
Appliance, Fixation, Spinal Intervertebral Body
Applicant
SYNTHES SPINE
1302 WRIGHTS LANE EAST
WEST CHESTER, PA 19380 US
Other 510(k) Applications for this Company
Contact
STACEY BONNELL
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
04/21/2009
Decision Date
07/10/2009
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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