FDA Product Code QPQ: Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-fixed
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.
Leading manufacturers include Ortho-Space , Ltd..
1
Total
0
Cleared
395d
Avg days
2021
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-fixed Devices (Product Code QPQ)
1 devices
Not Cleared
Jul 12, 2021
InSpace Subacromial Tissue Spacer System
Ortho-Space , Ltd.
Orthopedic
395d
About Product Code QPQ - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code QPQ since 2021, with 0 receiving FDA clearance (average review time: 395 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.
QPQ devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →