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FDA 510(k) Application Details - K110655
Device Classification Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
More FDA Info for this Device
510(K) Number
K110655
Device Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant
MAHE MEDICAL GMBH
SCHWARZWALDSTRASSE 5
TUTTLINGEN, BW 78532 GR
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Contact
ANDREA PECSI
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Regulation Number
888.3070
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Classification Product Code
NKB
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More FDA Info for this Product Code
Date Received
03/07/2011
Decision Date
10/27/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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