FDA 510(k) Application Details - K183071

Device Classification Name

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510(K) Number K183071
Device Name VLIFT-s Vertebral Body Replacement System
Applicant Stryker Spine
2 Pearl Court
Allendale, NJ 07401 US
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Contact Renee Norby
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Regulation Number

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Classification Product Code PLR
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Date Received 11/05/2018
Decision Date 01/10/2019
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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