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De Novo DEN200039
- Device
- InSpace Subacromial Tissue Spacer System
- Contact
- katie farraro
- De Novo number
- DEN200039
- Product code
- QPQ
- Regulation
- 888.3630
- Classification name
- shoulder spacer for massive irreparable rotator cuff tear, resorbable, inflatable, non-fixed
- Decision
- granted (DENG)
- Decision date
- 2021-07-12
- Date received
- 2020-06-12
- Classification advisory
- Orthopedic
- Review advisory
- Orthopedic
- Type
- Direct
Current FDA Classification#
- Product code
- QPQ
- Device name
- Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation
- 888.3630
- Implant
- Y
- Life sustain/support
- N