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FDA 510(k) Application Details - K980485
Device Classification Name
Orthosis, Spinal Pedicle Fixation
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510(K) Number
K980485
Device Name
Orthosis, Spinal Pedicle Fixation
Applicant
ACROMED CORP.
3303 CARNEGIE AVE.
CLEVELAND, OH 44115 US
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Contact
WILLIAM CHRISTIANSON
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Regulation Number
888.3070
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Classification Product Code
MNI
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More FDA Info for this Product Code
Date Received
02/09/1998
Decision Date
10/21/1998
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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