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FDA 510(k)

02810-01/02810-02 ORTHORANGER II/02810-3 ROM 360

K-Number: K913079 · 1991-09-25

ApplicantLucas Sensing Systems, Inc.
Decision Date1991-09-25
Product CodeKQX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

02810-01/02810-02 ORTHORANGER II/02810-3 ROM 360 is the device name listed in this FDA 510(k) record. The listed applicant is Lucas Sensing Systems, Inc.. It received FDA 510(k) clearance on 1991-09-25 under 510(k) number K913079. The device is classified under product code KQX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 02810-01/02810-02 ORTHORANGER II/02810-3 ROM 360?

02810-01/02810-02 ORTHORANGER II/02810-3 ROM 360 is a medical device that received FDA 510(k) clearance on 1991-09-25. The listed applicant is Lucas Sensing Systems, Inc.. The 510(k) number is K913079.

When did 02810-01/02810-02 ORTHORANGER II/02810-3 ROM 360 receive FDA 510(k) clearance?

02810-01/02810-02 ORTHORANGER II/02810-3 ROM 360 received FDA 510(k) clearance on 1991-09-25, under 510(k) number K913079.

Who is the listed applicant for 02810-01/02810-02 ORTHORANGER II/02810-3 ROM 360?

The FDA 510(k) record lists Lucas Sensing Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 02810-01/02810-02 ORTHORANGER II/02810-3 ROM 360?

The FDA product code for 02810-01/02810-02 ORTHORANGER II/02810-3 ROM 360 is KQX.

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Related Devices (Code: KQX)

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.

K011827ORTELIUS 800Orthoscan , Ltd.K971079INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWAREInterlogics, Inc.K9623773D-SPINESkill Technologies, Inc.K961212SPINAL TOUCHFasstechK954647INCLINOMETERJ-Tech, Inc.K943929DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS)Greenleaf Medical Systems, Inc.

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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