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FDA 510(k) Application Details - K042953
Device Classification Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
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510(K) Number
K042953
Device Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant
GLOBUS MEDICAL, INC.
303 SCHELL LANE
PHOENIXVILLE, PA 19460 US
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Contact
KELLY J 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
10/26/2004
Decision Date
11/22/2004
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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