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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 a medical device manufactured by CarboFix Orthopedics , Ltd.. It received FDA 510(k) clearance on 2020-08-05 under approval 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. It is manufactured by CarboFix Orthopedics , Ltd.. The 510(k) number is K201251.

When was CarboClear Navigated Instruments approved by the FDA?

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

What company makes CarboClear Navigated Instruments?

CarboClear Navigated Instruments is manufactured by CarboFix Orthopedics , Ltd..

What is the FDA product code for CarboClear Navigated Instruments?

The FDA product code for CarboClear Navigated Instruments is OLO.

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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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