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FDA 510(k) Application Details - K962984
Device Classification Name
Appliance, Fixation, Spinal Interlaminal
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510(K) Number
K962984
Device Name
Appliance, Fixation, Spinal Interlaminal
Applicant
ACROMED CORP.
3303 CARNEGIE AVE.
CLEVELAND, OH 44115 US
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Contact
WILLIAM CHRISTIANSON
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Regulation Number
888.3050
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Classification Product Code
KWP
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More FDA Info for this Product Code
Date Received
08/01/1996
Decision Date
11/27/1996
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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