# New Era Orthopedics, LLC

- Location (FDA's records): Hummelstown, PA
- FDA decisions: 2 (2014–2015): 2 510(k) clearances
- Product codes: MNI (1), JWH (1)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Pipeline Orthopedics: 3 (https://510kreport.com/company/pipeline-orthopedics)
- New Era Orthopaedics, LLC: 1 (https://510kreport.com/company/new-era-orthopaedics)
- Globus Medical, Inc.: 1 (https://510kreport.com/company/globus-medical)

## Recent decisions
- K150647: Polyscrew Pedicle Screw System (Apr 8, 2015)
- K142388: Neo Total Knee System (Dec 5, 2014)

Source page: https://510kreport.com/company/new-era-orthopedics