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FDA 510(k) Application Details - K081849
Device Classification Name
More FDA Info for this Device
510(K) Number
K081849
Device Name
BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE
Applicant
BLACKSTONE MEDICAL, INC.
1211 HAMBURG TURNPIKE
SUITE 300
WAYNE, NJ 07470 US
Other 510(k) Applications for this Company
Contact
WHITNEY G TORNING
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OVD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/30/2008
Decision Date
08/28/2008
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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