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FDA 510(k) Application Details - K993810
Device Classification Name
Orthosis, Spondyloisthesis Spinal Fixation
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510(K) Number
K993810
Device Name
Orthosis, Spondyloisthesis Spinal Fixation
Applicant
DANEK MEDICAL, INC.
1800 PYRAMID PL.
MEMPHIS, TN 38132 US
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Contact
RICHARD W TREHARNE
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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
11/10/1999
Decision Date
02/03/2000
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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