EMPOWR Stem Extender, 50mm— 510(k) K230441
Substantially EquivalentEncore Medical, L.P Dba Enovis
FDA 510(k) clearance K230441 for EMPOWR Stem Extender, 50mm, Substantially Equivalent on 2023-03-17. Applicant: Encore Medical, L.P Dba Enovis.
Clearance details
- Applicant
- Encore Medical, L.P Dba Enovis
- Product code
- Code JWH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Austin, TX, US
Adverse events under product code JWH
product code JWH- Death
- 26
- Injury
- 51,564
- Malfunction
- 9,725
- Other
- 9
- Total
- 61,324
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.