DeNovo ID | DEN200039 |
Device Name: | InSpace Subacromial Tissue Spacer System |
Classification | Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-fixed |
Applicant | Ortho-Space Ltd. 7 Halamish St. Caesarea, IL 3079579 |
Contact | Katie Farraro |
Product Code | QPQ |
CFR Regulation Number | 888.3630 [🔎] |
Decision | Granted (DENG) |
510(k) Premarket Notification | Device 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 Board | Orthopedic |
Classification Advisory | Orthopedic |
Type | Direct |
Date Received | 2020-06-12 |
Decision Date | 2021-07-12 |
Reclassification Order: | Reclassification Order |