510(k) clearance
AltiVate Reverse® Glenosphere with RAVN™ Technology
- 510(k) number
- K263086
- Applicant
- Encore Medical L.P.
- Decision date
- Oct 2, 2026
- Date received
- Sep 2, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- PHX
- Device type
- Shoulder Prosthesis, Reverse Configuration
- Device class
- Class II
- Regulation
- 21 CFR 888.3660
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Austin, TX, US