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FDA 510(k)

ExactechGPS Total Shoulder Application, Equinoxe Planning Software

K-Number: K162567 · 2017-04-05

ApplicantBlue Ortho
Decision Date2017-04-05
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ExactechGPS Total Shoulder Application, Equinoxe Planning Software is a medical device manufactured by Blue Ortho. It received FDA 510(k) clearance on 2017-04-05 under approval number K162567. 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, Equinoxe Planning Software?

ExactechGPS Total Shoulder Application, Equinoxe Planning Software is a medical device that received FDA 510(k) clearance on 2017-04-05. It is manufactured by Blue Ortho. The 510(k) number is K162567.

When was ExactechGPS Total Shoulder Application, Equinoxe Planning Software approved by the FDA?

ExactechGPS Total Shoulder Application, Equinoxe Planning Software received FDA 510(k) clearance on 2017-04-05, under approval number K162567.

What company makes ExactechGPS Total Shoulder Application, Equinoxe Planning Software?

ExactechGPS Total Shoulder Application, Equinoxe Planning Software is manufactured by Blue Ortho.

What is the FDA product code for ExactechGPS Total Shoulder Application, Equinoxe Planning Software?

The FDA product code for ExactechGPS Total Shoulder Application, Equinoxe Planning Software is OLO.

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Related PubMed Literature

PMID: 41533265 Modernizing Medical Software Regulation in Bangladesh: A Roadmap for Risk-Based SaMD Oversight. Journal of medical systems (2026) PMID: 41448921 [Research on Standardized Testing Processes and Methods of Graphics Measurement Functions of Medical Device Software]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025) PMID: 41116086 Eye-tracking-based tablet application for enhanced cognitive assessment: a clinical trial for software as a medical device (SaMD). GeroScience (2025) PMID: 40948288 [Research on Application of Medical Device Real-World Evidence in Regulatory Decisions of the United States]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

Other Devices by Blue Ortho

K152764EXACTECH GPS K173372ExactechGPS Total Shoulder Application K193618ExactechGPS System K213877ExactechGPS® System K213546ExactechGPS Total Shoulder Application, Equinoxe Planning Software K232521ExactechGPS® Total Ankle Application

View all 8 devices →

Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

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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