G7 Freedom and Offset Liners, Freedom Head, Size 32— 510(k) K142882
Substantially EquivalentBiomet, Inc.
FDA 510(k) clearance K142882 for G7 Freedom and Offset Liners, Freedom Head, Size 32, Substantially Equivalent on 2015-02-10. Applicant: Biomet, Inc..
Clearance details
- Applicant
- Biomet, Inc.
- Product code
- Code LPH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Adverse events under product code LPH
product code LPH- Death
- 73
- Injury
- 31,640
- Malfunction
- 3,358
- Other
- 2
- Total
- 35,073
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.