FDA 510(k)

ExactechGPS Total Shoulder Application

K-Number: K173372 · 2017-11-24

Decision Date2017-11-24

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

ExactechGPS Total Shoulder Application is a medical device manufactured by Blue Ortho. It received FDA 510(k) clearance on 2017-11-24 under approval number K173372. 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 ExactechGPS Total Shoulder Application?

ExactechGPS Total Shoulder Application is a medical device that received FDA 510(k) clearance on 2017-11-24. It is manufactured by Blue Ortho. The 510(k) number is K173372.

When was ExactechGPS Total Shoulder Application approved by the FDA?

ExactechGPS Total Shoulder Application received FDA 510(k) clearance on 2017-11-24, under approval number K173372.

What company makes ExactechGPS Total Shoulder Application?

ExactechGPS Total Shoulder Application is manufactured by Blue Ortho.

What is the FDA product code for ExactechGPS Total Shoulder Application?

The FDA product code for ExactechGPS Total Shoulder Application is OLO.

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Related PubMed Literature

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Other Devices by Blue Ortho

K152764EXACTECH GPS K162567ExactechGPS Total Shoulder Application, Equinoxe Planning Software K193618ExactechGPS System K213877ExactechGPS® System K213546ExactechGPS Total Shoulder Application, Equinoxe Planning Software K232521ExactechGPS® Total Ankle Application

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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.