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FDA 510(k) Application Details - K960451
Device Classification Name
Orthosis, Spondyloisthesis Spinal Fixation
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510(K) Number
K960451
Device Name
Orthosis, Spondyloisthesis Spinal Fixation
Applicant
BUCKMAN CO., INC.
1000 BURNETT AVE.
SUITE 450
CONCORD, CA 94520 US
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Contact
DAVID W SCHLERF
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Regulation Number
888.3070
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Classification Product Code
MNH
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More FDA Info for this Product Code
Date Received
01/30/1996
Decision Date
04/18/1996
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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