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FDA 510(k) Application Details - K110280
Device Classification Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
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510(K) Number
K110280
Device Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant
GLOBUS MEDICAL INC.
2560 GENERAL ARMISTEAD AVE.
AUDUBON, PA 19403 US
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Contact
KELLY J BAKER
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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
01/31/2011
Decision Date
07/06/2011
Decision
SESU - SE - WITH LIMITATIONS
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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