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FDA 510(k) Application Details - K220610
Device Classification Name
More FDA Info for this Device
510(K) Number
K220610
Device Name
SOLO-L
Applicant
Aurora Spine Inc
1930 Palomar Point Way, Suite #103
Carlsbad, CA 92008 US
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Contact
Laszlo Garamszegi
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Regulation Number
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Classification Product Code
OVD
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More FDA Info for this Product Code
Date Received
03/03/2022
Decision Date
05/27/2022
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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