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FDA 510(k)

Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws

K-Number: K223933 · 2023-09-25

ApplicantExactech, Inc.
Decision Date2023-09-25
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws is a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2023-09-25 under approval number K223933. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws?

Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws is a medical device that received FDA 510(k) clearance on 2023-09-25. It is manufactured by Exactech, Inc.. The 510(k) number is K223933.

When was Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws approved by the FDA?

Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws received FDA 510(k) clearance on 2023-09-25, under approval number K223933.

What company makes Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws?

Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws is manufactured by Exactech, Inc..

What is the FDA product code for Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws?

The FDA product code for Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws is HRS.

Related Clinical Trials

NCT06409559 Rim Plate to Buttress Plate for Posterior Wall Acetabular Fractures With and Without Inter-fragmentary Screws RECRUITING NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED NCT07520851 Efficacy of the Buzzy System on Pain and Fear Reduction in Elbow Fracture Pin Removal RECRUITING NCT05367505 Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the Pelvis RECRUITING NCT05773352 Perform® Humeral System - Fracture Study (PFX) ACTIVE_NOT_RECRUITING NCT07153120 Erich Arch Bars, IMF Screws and Hybrid Arch Bars in the Management of Mandibular Fractures COMPLETED

Other Devices by Exactech, Inc.

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Related Devices (Code: HRS)

K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc. K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG

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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