Neo Total Knee System— 510(k) K142388
Substantially EquivalentNew Era Orthopedics, LLC
FDA 510(k) clearance K142388 for Neo Total Knee System, Substantially Equivalent on 2014-12-05. Applicant: New Era Orthopedics, LLC.
Clearance details
- Applicant
- New Era Orthopedics, LLC
- Product code
- Code JWH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hummelstown, PA, 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.