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FDA 510(k) Application Details - K960533
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K960533
Device Name
Screw, Fixation, Bone
Applicant
KINETIKOS MEDICAL, INC.
3950 SORRENTO VALLEY BLVD.,
SAN DIEGO, CA 92121 US
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Contact
MARK G URBANSKI
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
HWC
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More FDA Info for this Product Code
Date Received
02/07/1996
Decision Date
03/25/1996
Decision
SN - Substantially Equivalent for Some Indications
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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