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FDA 510(k)

Black Diamond™ POCT Spinal System

K-Number: K222107 · 2022-11-03

ApplicantOsseus Fusion Systems
Decision Date2022-11-03
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Black Diamond™ POCT Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Osseus Fusion Systems. It received FDA 510(k) clearance on 2022-11-03 under 510(k) number K222107. 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 Black Diamond™ POCT Spinal System?

Black Diamond™ POCT Spinal System is a medical device that received FDA 510(k) clearance on 2022-11-03. The listed applicant is Osseus Fusion Systems. The 510(k) number is K222107.

When did Black Diamond™ POCT Spinal System receive FDA 510(k) clearance?

Black Diamond™ POCT Spinal System received FDA 510(k) clearance on 2022-11-03, under 510(k) number K222107.

Who is the listed applicant for Black Diamond™ POCT Spinal System?

The FDA 510(k) record lists Osseus Fusion Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Black Diamond™ POCT Spinal System?

The FDA product code for Black Diamond™ POCT Spinal System is NKG.

Other records listing Osseus Fusion Systems 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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