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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name shoulder spacer for massive irreparable rotator cuff tear, resorbable, inflatable, non-fixed
De Novo Number DEN200039
Device Name InSpace Subacromial Tissue Spacer System
Ortho-Space Ltd.
7 halamish st.
caesarea,  IL 3079579
Contact katie farraro
Regulation Number888.3630
Classification Product Code
Date Received06/12/2020
Decision Date 07/12/2021
Decision granted (DENG)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Reclassification Order Reclassification Order
Type Direct