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FDA 510(k)

CarboClear® Cervical Navigated Instruments

K-Number: K263154 · 2026-10-09

ApplicantCarboFix Orhtopedics , Ltd.
Decision Date2026-10-09
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CarboClear® Cervical Navigated Instruments is the device name listed in this FDA 510(k) record. The listed applicant is CarboFix Orhtopedics , Ltd.. It received FDA 510(k) clearance on 2026-10-09 under 510(k) number K263154. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CarboClear® Cervical Navigated Instruments?

CarboClear® Cervical Navigated Instruments is a medical device that received FDA 510(k) clearance on 2026-10-09. The listed applicant is CarboFix Orhtopedics , Ltd.. The 510(k) number is K263154.

When did CarboClear® Cervical Navigated Instruments receive FDA 510(k) clearance?

CarboClear® Cervical Navigated Instruments received FDA 510(k) clearance on 2026-10-09, under 510(k) number K263154.

Who is the listed applicant for CarboClear® Cervical Navigated Instruments?

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

What is the FDA product code for CarboClear® Cervical Navigated Instruments?

The FDA product code for CarboClear® Cervical Navigated Instruments is OLO.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Related Devices (Code: OLO)

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.

K262257Spine Planning (3.0); Spine & Trauma Navigation; Alignment System SpineBrainlab SEK262506Remex Spine Surgery Navigation - Universal InstrumentsRemex Medical Corp.K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK 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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