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FDA 510(k) Application Details - K183071
Device Classification Name
More FDA Info for this Device
510(K) Number
K183071
Device Name
VLIFT-s Vertebral Body Replacement System
Applicant
Stryker Spine
2 Pearl Court
Allendale, NJ 07401 US
Other 510(k) Applications for this Company
Contact
Renee Norby
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
PLR
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More FDA Info for this Product Code
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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