Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid— 510(k) K241491
Substantially EquivalentStryker Corporation (Tornier, S.A.S.)
FDA 510(k) clearance K241491 for Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid, Substantially Equivalent on 2024-10-10. Applicant: Stryker Corporation (Tornier, S.A.S.).
Clearance details
- Applicant
- Stryker Corporation (Tornier, S.A.S.)
- Product code
- Code PHX
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montbonnot-Saint-Martin, FR
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.