K252788
- 510(k) number
- K252788
- Device name
- Tornier Perform Reversed Monopost Glenoid (Perform Mono)
- Applicant
- Tornier, Inc. MN · US
- Product code
- PHX — Shoulder Prosthesis, Reverse Configuration
- Decision date
- 2026-01-08
- Date received
- 2025-09-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K252788.pdf
Official FDA record: K252788
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.