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FDA 510(k)

CarboClear Navigated Instruments

K-Number: K201251 · 2020-08-05

ApplicantCarboFix Orthopedics , Ltd.
Decision Date2020-08-05
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CarboClear Navigated Instruments is the device name listed in this FDA 510(k) record. The listed applicant is CarboFix Orthopedics , Ltd.. It received FDA 510(k) clearance on 2020-08-05 under 510(k) number K201251. 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 Navigated Instruments?

CarboClear Navigated Instruments is a medical device that received FDA 510(k) clearance on 2020-08-05. The listed applicant is CarboFix Orthopedics , Ltd.. The 510(k) number is K201251.

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

CarboClear Navigated Instruments received FDA 510(k) clearance on 2020-08-05, under 510(k) number K201251.

Who is the listed applicant for CarboClear Navigated Instruments?

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

What is the FDA product code for CarboClear Navigated Instruments?

The FDA product code for CarboClear Navigated Instruments is OLO.

Other records listing CarboFix Orthopedics , Ltd. as applicant

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.

K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemK243106CarboClear® Hybrid Pedicle Screw SystemK233793CarboClear® X Pedicle Screw SystemK240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone CementK233989CarboClear® Posterior Cervical Screw SystemK233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments

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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.

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.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential RoboticsK261852OTS HipOrtoma AB

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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