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FDA 510(k)

ExactechGPS® Total Ankle Application

K-Number: K232521 · 2023-11-16

ApplicantBlue Ortho
Decision Date2023-11-16
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ExactechGPS® Total Ankle Application is a medical device manufactured by Blue Ortho. It received FDA 510(k) clearance on 2023-11-16 under approval number K232521. 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 Ankle Application?

ExactechGPS® Total Ankle Application is a medical device that received FDA 510(k) clearance on 2023-11-16. It is manufactured by Blue Ortho. The 510(k) number is K232521.

When was ExactechGPS® Total Ankle Application approved by the FDA?

ExactechGPS® Total Ankle Application received FDA 510(k) clearance on 2023-11-16, under approval number K232521.

What company makes ExactechGPS® Total Ankle Application?

ExactechGPS® Total Ankle Application is manufactured by Blue Ortho.

What is the FDA product code for ExactechGPS® Total Ankle Application?

The FDA product code for ExactechGPS® Total Ankle Application is OLO.

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Related PubMed Literature

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) PMID: 33125510 Effectiveness of vibrational forces on orthodontic treatment : A randomized, controlled clinical trial. Journal of orofacial orthopedics = Fortschritte der Kieferorthopadie : Organ/official journal Deutsche Gesellschaft fur Kieferorthopadie (2021)

Other Devices by Blue Ortho

K152764EXACTECH GPS K173372ExactechGPS Total Shoulder Application K162567ExactechGPS Total Shoulder Application, Equinoxe Planning Software K193618ExactechGPS System K213877ExactechGPS® System K213546ExactechGPS Total Shoulder Application, Equinoxe Planning Software

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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