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FDA 510(k) Application Details - K213266
Device Classification Name
More FDA Info for this Device
510(K) Number
K213266
Device Name
Inspan ScrewLES Fusion System
Applicant
LESpine Innovations, LLC
350 Main Street, 2nd Floor
Malden, MA 02148 US
Other 510(k) Applications for this Company
Contact
John Sullivan
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Regulation Number
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Classification Product Code
PEK
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More FDA Info for this Product Code
Date Received
09/30/2021
Decision Date
12/03/2021
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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