DEN200039 is an FDA 510(k) submission for the InSpace Subacromial Tissue Spacer System. This device is classified as a Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-fixed (Class II - Special Controls, product code QPQ).
Submitted by Ortho-Space , Ltd. (Caesarea, IL). The FDA issued a Not Cleared (DENG) decision on July 12, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3630. 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..
| 510(k) Number | DEN200039 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | June 12, 2020 |
| Decision Date | July 12, 2021 |
| Days to Decision | 395 days |
| Submission Type | Direct |
| Review Panel | Orthopedic (OR) |
| Summary | - |
| Product Code | QPQ - Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-fixed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3630 |
| Definition | 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. |