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FDA 510(k) Application Details - K061202
Device Classification Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
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510(K) Number
K061202
Device Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant
GLOBUS MEDICAL INC.
303 SCHELL LN.
PHOENIXVILLE, PA 19460 US
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Contact
KELLY BAKER
Other 510(k) Applications for this Contact
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
05/01/2006
Decision Date
07/20/2006
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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