Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System— 510(k) K260102
Substantially EquivalentStryker Corporation (Tornier, Inc.)
FDA 510(k) clearance K260102 for Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System, Substantially Equivalent on 2026-06-12. Applicant: Stryker Corporation (Tornier, Inc.).
Clearance details
- Applicant
- Stryker Corporation (Tornier, Inc.)
- Product code
- Code PHX
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bloomington, MN, US
Adverse events under product code PHX
product code PHX- Death
- 10
- Injury
- 9,705
- Malfunction
- 1,252
- Total
- 10,967
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.