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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 the device name listed in this FDA 510(k) record. The listed applicant is Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2025-05-13 under 510(k) 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. The listed applicant is Signature Orthopaedics Pty, Ltd.. The 510(k) number is K242674.

When did Freedom Posterior Cervical Screws receive FDA 510(k) clearance?

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

Who is the listed applicant for Freedom Posterior Cervical Screws?

The FDA 510(k) record lists Signature Orthopaedics Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Signature Orthopaedics Pty, Ltd. as applicant

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Related Devices (Code: NKG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemCarboFix Orthopedics , Ltd.K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AGK253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.

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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