510(k) DEN200039
- Device
- InSpace Subacromial Tissue Spacer System
- Applicant
- Ortho-Space , Ltd.
- 510(k) number
- DEN200039
- Product code
- QPQ
- Decision
- Unknown (DENG)
- Decision date
- 2021-07-12
- Date received
- 2020-06-12
- Regulation
- 888.3630
- Classification name
- Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Katie Farraro
- Address
- 7 Halamish St. Caesarea IL 3079579 3079579
FDA Registration Numbers#
- 3008729892
- 3016573902
- 2936485
Source Documents#
510(k) summary PDF not indicated by FDA