HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PA— 510(k) K113756
Substantially EquivalentEncore Medical L.P.
FDA 510(k) clearance K113756 for HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PA, Substantially Equivalent on 2012-03-14. Applicant: Encore Medical L.P..
Clearance details
- Applicant
- Encore Medical L.P.
- Product code
- Code OIY
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Austin, TX, US
Adverse events under product code OIY
product code OIY- Injury
- 607
- Total
- 607
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.