510(k) DEN200039
DEN200039 is an FDA 510(k) premarket notification submitted by Ortho-Space , Ltd. for the device "InSpace Subacromial Tissue Spacer System". The FDA issued a decision of De Novo Granted on July 12, 2021. The device falls under product code QPQ (Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed), a Class II device regulated under 21 CFR 888.3630.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- July 12, 2021
- Date Received
- June 12, 2020
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed
- Device Class
- Class II
- Regulation Number
- 888.3630
- Review Panel
- OR
- Submission Type
A resorbable shoulder spacer is intended to act as a temporary spacer, creating a physical barrier between tissues in the shoulder, for the treatment of massive irreparable rotator cuff tears.