InSpace Subacromial Tissue Spacer System

Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-fixed

Ortho-Space Ltd.

The following data is part of a De Novo classification by Ortho-space Ltd. with the FDA for Inspace Subacromial Tissue Spacer System.

Pre-market Notification Details

DeNovo IDDEN200039
Device Name:InSpace Subacromial Tissue Spacer System
ClassificationShoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-fixed
Applicant Ortho-Space Ltd. 7 Halamish St. Caesarea,  IL 3079579
ContactKatie Farraro
Product CodeQPQ  
CFR Regulation Number888.3630 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardOrthopedic
Classification AdvisoryOrthopedic
TypeDirect
Date Received2020-06-12
Decision Date2021-07-12
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
17290013396065 DEN200039 000
17290013396058 DEN200039 000
17290013396041 DEN200039 000

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