HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712— 510(k) K091956
Substantially EquivalentEncore Medical L.P.
FDA 510(k) clearance K091956 for HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712, Substantially Equivalent on 2010-09-28. 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
- Traditional
- 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.