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FDA 510(k)

ARTHROSTEER ABLATOR & COAGULATOR, MODELS: REF 1070 & 1080

K-Number: K093086 · 2010-02-23

ApplicantOrthodynamix, LLC
Decision Date2010-02-23
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ARTHROSTEER ABLATOR & COAGULATOR, MODELS: REF 1070 & 1080 is the device name listed in this FDA 510(k) record. The listed applicant is Orthodynamix, LLC. It received FDA 510(k) clearance on 2010-02-23 under 510(k) number K093086. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTHROSTEER ABLATOR & COAGULATOR, MODELS: REF 1070 & 1080?

ARTHROSTEER ABLATOR & COAGULATOR, MODELS: REF 1070 & 1080 is a medical device that received FDA 510(k) clearance on 2010-02-23. The listed applicant is Orthodynamix, LLC. The 510(k) number is K093086.

When did ARTHROSTEER ABLATOR & COAGULATOR, MODELS: REF 1070 & 1080 receive FDA 510(k) clearance?

ARTHROSTEER ABLATOR & COAGULATOR, MODELS: REF 1070 & 1080 received FDA 510(k) clearance on 2010-02-23, under 510(k) number K093086.

Who is the listed applicant for ARTHROSTEER ABLATOR & COAGULATOR, MODELS: REF 1070 & 1080?

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

What is the FDA product code for ARTHROSTEER ABLATOR & COAGULATOR, MODELS: REF 1070 & 1080?

The FDA product code for ARTHROSTEER ABLATOR & COAGULATOR, MODELS: REF 1070 & 1080 is GEI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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