Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ExactechGPS Total Shoulder Application, Equinoxe Planning Software

K-Number: K213546 · 2022-01-06

ApplicantBlue Ortho
Decision Date2022-01-06
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 2022-01-06 under approval number K213546. 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 2022-01-06. It is manufactured by Blue Ortho. The 510(k) number is K213546.

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 2022-01-06, under approval number K213546.

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.

Related Clinical Trials

NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT06420323 NovoX®Cup as Primary Dressing After Breast Reduction ACTIVE_NOT_RECRUITING NCT07464275 Performance Assessment of the MAGENTA Blast Algorithm for Embryo Prediction COMPLETED NCT07370051 Effect of Topical Oxygen and LED Light Therapy on Nipple Crack NOT_YET_RECRUITING NCT07409571 Palatal Wound Healing After Free Gingival Graft Surgery RECRUITING NCT07602933 Photobiomodulation Effects on Fatigue and Muscle Damage Induced by NMES NOT_YET_RECRUITING

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 K162567ExactechGPS Total Shoulder Application, Equinoxe Planning Software K193618ExactechGPS System K213877ExactechGPS® System 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.

↑