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FDA 510(k) Applications Submitted by SANDIE ROTH
FDA 510(k) Number
Submission Date
Device Name
Applicant
K201072
04/22/2020
Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161
Ensemble Orthopedics, LLC
K131296
05/06/2013
VARILIFT-L INTERBODY FUSION DEVICE
WENZEL SPINE, INC.
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