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FDA 510(k)

ExactechGPS® System

K-Number: K213877 · 2022-05-02

ApplicantBlue Ortho
Decision Date2022-05-02
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ExactechGPS® System is the device name listed in this FDA 510(k) record. The listed applicant is Blue Ortho. It received FDA 510(k) clearance on 2022-05-02 under 510(k) number K213877. 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® System?

ExactechGPS® System is a medical device that received FDA 510(k) clearance on 2022-05-02. The listed applicant is Blue Ortho. The 510(k) number is K213877.

When did ExactechGPS® System receive FDA 510(k) clearance?

ExactechGPS® System received FDA 510(k) clearance on 2022-05-02, under 510(k) number K213877.

Who is the listed applicant for ExactechGPS® System?

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

What is the FDA product code for ExactechGPS® System?

The FDA product code for ExactechGPS® System is OLO.

Other records listing Blue Ortho 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.

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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.

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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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