AltiVate Reverse® Glenoid
FDA 510(k) clearance K233481 · decided 2024-05-29
Clearance details
- K-number
- K233481
- Device name
- AltiVate Reverse® Glenoid
- Applicant
- Encore Medical L.P.
- Decision
- Substantially Equivalent
- Date received
- 2023-10-26
- Decision date
- 2024-05-29
- Days to decision
- 216 days
- Clearance type
- Traditional
- Product code
- PHX
- Device class
- 2
- Regulation number
- 888.3660
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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