Medacta Shoulder System
FDA 510(k) clearance K192967 · decided 2020-03-25
Clearance details
- K-number
- K192967
- Device name
- Medacta Shoulder System
- Applicant
- Medacta International S.A.
- Decision
- Substantially Equivalent
- Date received
- 2019-10-23
- Decision date
- 2020-03-25
- Days to decision
- 154 days
- Clearance type
- Traditional
- Product code
- PHX
- Device class
- 2
- Regulation number
- 888.3660
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Castel San Pietro, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.