ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS— 510(k) K082398
Substantially EquivalentEncore Medical L.P.
FDA 510(k) clearance K082398 for ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS, Substantially Equivalent on 2008-10-15. Applicant: Encore Medical L.P..
Clearance details
- Applicant
- Encore Medical L.P.
- Product code
- Code LZO
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- 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.