Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate— 510(k) K172502
Substantially EquivalentBiomet Manufacturing Corp
FDA 510(k) clearance K172502 for Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate, Substantially Equivalent on 2018-01-03. Applicant: Biomet Manufacturing Corp.
Clearance details
- Applicant
- Biomet Manufacturing Corp
- Product code
- Code PHX
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, 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.