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FDA 510(k) Application Details - K102143
Device Classification Name
Staple, Fixation, Bone
More FDA Info for this Device
510(K) Number
K102143
Device Name
Staple, Fixation, Bone
Applicant
SUSPENSION ORTHOPAEDIC SOLUTIONS, LLC
80 SHELTON TECHNOLOGY CENTER
SHELTON, CT 06484 US
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Contact
JOSEPH AZARY
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
JDR
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More FDA Info for this Product Code
Date Received
07/30/2010
Decision Date
12/08/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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