K251184
- 510(k) number
- K251184
- Device name
- AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System
- Applicant
- Encore Medical L.P. TX · US
- Product code
- PHX — Shoulder Prosthesis, Reverse Configuration
- Decision date
- 2025-05-16
- Date received
- 2025-04-16
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K251184.pdf
Official FDA record: K251184
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.