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FDA 510(k) Application Details - K121732
Device Classification Name
Orthosis, Spine, Plate, Laminoplasty, Metal
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510(K) Number
K121732
Device Name
Orthosis, Spine, Plate, Laminoplasty, Metal
Applicant
GLOBUS MEDICAL INC.
2560 GENERAL ARMISTEAD AVE.
AUDUBON, PA 19403 US
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Contact
SARAH MARIE FITZGERALD
Other 510(k) Applications for this Contact
Regulation Number
888.3050
More FDA Info for this Regulation Number
Classification Product Code
NQW
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More FDA Info for this Product Code
Date Received
06/13/2012
Decision Date
10/31/2012
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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