FDA 510(k) Application Details - K200338

Device Classification Name

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510(K) Number K200338
Device Name ProLift Lateral Fixated
Applicant Life Spine Inc.
13951 S Quality Drive
Huntley, IL 60142 US
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Contact Angela Batker
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Regulation Number

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Classification Product Code OVD
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Date Received 02/11/2020
Decision Date 04/17/2020
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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