Smart SPACE Shoulder System
FDA 510(k) clearance K202454 · decided 2020-12-28
Clearance details
- K-number
- K202454
- Device name
- Smart SPACE Shoulder System
- Applicant
- Techmah Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2020-08-27
- Decision date
- 2020-12-28
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- QHE
- Device class
- 2
- Regulation number
- 888.3660
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Knoxville, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.