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FDA 510(k) Application Details - K061229
Device Classification Name
Appliance, Fixation, Spinal Intervertebral Body
More FDA Info for this Device
510(K) Number
K061229
Device Name
Appliance, Fixation, Spinal Intervertebral Body
Applicant
BLACKSTONE MEDICAL, INC.
1211 HAMBURG TURNPIKE
SUITE 300
WAYNE, NJ 07470 US
Other 510(k) Applications for this Company
Contact
MARTIN SPRUNCK
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
05/02/2006
Decision Date
07/24/2006
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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