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FDA 510(k) Application Details - K200541
Device Classification Name
More FDA Info for this Device
510(K) Number
K200541
Device Name
HiveÖ Stand-alone Anterior Lumbar Interbody System
Applicant
HD LifeSciences LLC
12 Gill St Suite 4500
Woburn, MA 01801 US
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Contact
John Sullivan
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Regulation Number
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Classification Product Code
OVD
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Date Received
03/03/2020
Decision Date
04/28/2020
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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