ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS STEMS, THE ENCORE VITALITY STEMS AND SL AND— 510(k) K965002
Substantially EquivalentEncore Orthopedics, Inc.
FDA 510(k) clearance K965002 for ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS STEMS, THE ENCORE VITALITY STEMS AND SL AND, Substantially Equivalent on 1997-06-27. Applicant: Encore Orthopedics, Inc..
Clearance details
- Applicant
- Encore Orthopedics, Inc.
- Product code
- Code LZO
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
Adverse events under product code LZO
product code LZO- Death
- 17
- Injury
- 12,942
- Malfunction
- 1,756
- Total
- 14,715
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.