InSpace Subacromial Tissue Spacer System
FDA 510(k) clearance DEN200039 · decided 2021-07-12
Clearance details
- K-number
- DEN200039
- Device name
- InSpace Subacromial Tissue Spacer System
- Applicant
- Ortho-Space , Ltd.
- Decision
- Unknown
- Date received
- 2020-06-12
- Decision date
- 2021-07-12
- Days to decision
- 395 days
- Clearance type
- Direct
- Product code
- QPQ
- Device class
- 2
- Regulation number
- 888.3630
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Caesarea, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.