RSP MONOBLOCK STEM WITH P2 COATING, SIZE 6— 510(k) K140904
Substantially EquivalentEncore Medical L.P.
FDA 510(k) clearance K140904 for RSP MONOBLOCK STEM WITH P2 COATING, SIZE 6, Substantially Equivalent on 2014-05-06. Applicant: Encore Medical L.P..
Clearance details
- Applicant
- Encore Medical L.P.
- Product code
- Code PHX
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Austin, TX, US
Adverse events under product code PHX
product code PHX- Death
- 10
- Injury
- 9,705
- Malfunction
- 1,252
- Total
- 10,967
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.