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FDA 510(k)

Freedom Posterior Cervical Screws

K-Number: K242674 · 2025-05-13

ApplicantSignature Orthopaedics Pty, Ltd.
Decision Date2025-05-13
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Freedom Posterior Cervical Screws is a medical device manufactured by Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2025-05-13 under approval number K242674. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Freedom Posterior Cervical Screws?

Freedom Posterior Cervical Screws is a medical device that received FDA 510(k) clearance on 2025-05-13. It is manufactured by Signature Orthopaedics Pty, Ltd.. The 510(k) number is K242674.

When was Freedom Posterior Cervical Screws approved by the FDA?

Freedom Posterior Cervical Screws received FDA 510(k) clearance on 2025-05-13, under approval number K242674.

What company makes Freedom Posterior Cervical Screws?

Freedom Posterior Cervical Screws is manufactured by Signature Orthopaedics Pty, Ltd..

What is the FDA product code for Freedom Posterior Cervical Screws?

The FDA product code for Freedom Posterior Cervical Screws is NKG.

Related Clinical Trials

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Related Devices (Code: NKG)

K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG K162300Reform® POCT SystemPrecision Spine, Inc. K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc. K161478Xenco Medical Posterior Cervical SystemXenco Medical, LLC K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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