# New Era Orthopaedics, LLC

- Location (FDA's records): Round Rock, TX
- FDA decisions: 1 (2015–2015): 1 510(k) clearance
- Product codes: MNI (1)
- Predicates its devices cite: 9 (0 its own); citations of its devices by later devices: 1 (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
- Stryker Spine: 2 (https://510kreport.com/company/stryker-spine)
- Cross Medical Products, Inc.: 2 (https://510kreport.com/company/cross-medical-products)
- Globus Medical, Inc.: 1 (https://510kreport.com/company/globus-medical)
- Buckman Co., Inc.: 1 (https://510kreport.com/company/buckman)
- Synthes Spine: 1 (https://510kreport.com/company/synthes-spine)
- Scient'X: 1 (https://510kreport.com/company/scient-x)
- Medtronic Sofamor Danek USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danek-usa)

## Firms that cite its devices most
- New Era Orthopedics, LLC: 1 (https://510kreport.com/company/new-era-orthopedics)

## Its most-cited devices
- K141253: New Era Orthopaedics Polyscrew Pedicle Screw System (2015), cited by 1

## Recent decisions
- K141253: New Era Orthopaedics Polyscrew Pedicle Screw System (Jan 9, 2015)

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