LINEAR POROUS COATED HIP STEM, SIZE 5; REVELATION HIP STEM, SIZE 8; FOUNDATION POROUS PRESS FIT STEM, SIZE 8— 510(k) K121024
Substantially EquivalentEncore Medical L.P.
FDA 510(k) clearance K121024 for LINEAR POROUS COATED HIP STEM, SIZE 5; REVELATION HIP STEM, SIZE 8; FOUNDATION POROUS PRESS FIT STEM, SIZE 8, Substantially Equivalent on 2012-06-19. Applicant: Encore Medical L.P.. Device class: 2.
Clearance details
- Device name as filed
- LINEAR POROUS COATED HIP STEM, SIZE 5; REVELATION HIP STEM, SIZE 8; FOUNDATION POROUS PRESS FIT STEM, SIZE 8;
- Applicant
- Encore Medical L.P.
- Product code
- Code LPH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3358
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
Recent devices under product code LPH
view allMore clearances from Encore Medical L.P.
view allAdverse events under product code LPH
product code LPH- Death
- 73
- Injury
- 31,640
- Malfunction
- 3,358
- Other
- 2
- Total
- 35,073
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.