ceramys femoral head system— 510(k) K241483
Substantially EquivalentEncore Medical L.P.
FDA 510(k) clearance K241483 for ceramys femoral head system, Substantially Equivalent on 2025-02-07. Applicant: Encore Medical L.P.. Device class: 2.
Clearance details
- Applicant
- Encore Medical L.P.
- Product code
- Code LZO
- Device class
- Class 2
- Regulation
- 21 CFR 888.3353
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
Recent devices under product code LZO
view allMore clearances from Encore Medical L.P.
view allAdverse 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.