Is this your brand? Sign in to claim ownership.

New Era Orthopaedics, LLC

Last updated May 23, 2026

What New Era Orthopaedics, LLC makes

New Era Orthopaedics, LLC manufactures the Polyscrew Pedicle Screw System, a spinal fixation device used for internal orthopaedic stabilization in surgical procedures.

The company’s products are regulated as Class II devices under FDA 510(k) clearance requirements and are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does New Era Orthopaedics, LLC manufacture?

New Era Orthopaedics, LLC specializes in spinal fixation devices. Specifically, they produce the Polyscrew Pedicle Screw System, which is designed for internal orthopaedic stabilization during surgical procedures. This device is intended to provide structural support to the spine.

Where is New Era Orthopaedics, LLC based?

New Era Orthopaedics, LLC is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and operational reach, particularly in the context of FDA compliance and market distribution.

How are the devices manufactured by New Era Orthopaedics, LLC classified under regulatory standards?

The devices produced by New Era Orthopaedics, LLC, such as the Polyscrew Pedicle Screw System, are classified as Class II medical devices. This classification under FDA regulations typically means they pose moderate risk and require premarket notification (510(k)) clearance to demonstrate substantial equivalence to a legally marketed predicate device.

Which regulatory registries or databases list the devices made by New Era Orthopaedics, LLC?

The devices manufactured by New Era Orthopaedics, LLC, including the Polyscrew Pedicle Screw System, are listed in the FDA’s 510(k) database. This registry is used to track devices that have undergone the 510(k) clearance process, ensuring transparency and compliance with FDA requirements for Class II devices.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: —

Catalogue (259)

Page 1 of 6

Device	Model / Reference	Registries	Class	Status
NEO Modera Pedicle Screw System	A	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	B	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	B	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	B	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	A	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	B	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	A	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	A	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	B	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	A	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	B	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	A	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	A	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	B	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	A	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	B	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	B	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	A	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	B	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	A	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	B	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	A	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	B	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	A	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	A	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	A	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	B	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	B	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	A	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	B	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	B	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	A	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	A	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	A	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	A	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	B	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	B	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	B	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	A	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	A	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	B	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	A	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	A	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	B	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	A	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	B	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	A	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	A	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	A	FDA UDI	Class II	Active
NEO Modera Pedicle Screw System	B	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

New Era Orthopaedics, LLC has one FDA recall record initiated on February 13, 2017, involving a retrospective recall of an instrument used with the Modera Modular Pedicle Screw system for spine fusion procedures. The recall was initiated due to a customer complaint regarding excessive forces applied to the shank insertion instrument, which resulted in a laser weld failure. The status of the recall is recorded as terminated.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Feb 13, 2017	Z-2604-2018	—	terminated	This is a retrospective recall of an instrument used in spine fusion procedures with Modera Modular Pedicle Screw system implants. The firm received a customer complaint in which excessive forces were applied to the shank insertion instrument and the laser weld failed.