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FDA 510(k)

ExtremiLOCK Lateral Ankle Fusion Plates

K-Number: K203479 · 2021-02-24

ApplicantOsteomed
Decision Date2021-02-24
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ExtremiLOCK Lateral Ankle Fusion Plates is a medical device manufactured by Osteomed. It received FDA 510(k) clearance on 2021-02-24 under approval number K203479. 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 ExtremiLOCK Lateral Ankle Fusion Plates?

ExtremiLOCK Lateral Ankle Fusion Plates is a medical device that received FDA 510(k) clearance on 2021-02-24. It is manufactured by Osteomed. The 510(k) number is K203479.

When was ExtremiLOCK Lateral Ankle Fusion Plates approved by the FDA?

ExtremiLOCK Lateral Ankle Fusion Plates received FDA 510(k) clearance on 2021-02-24, under approval number K203479.

What company makes ExtremiLOCK Lateral Ankle Fusion Plates?

ExtremiLOCK Lateral Ankle Fusion Plates is manufactured by Osteomed.

What is the FDA product code for ExtremiLOCK Lateral Ankle Fusion Plates?

The FDA product code for ExtremiLOCK Lateral Ankle Fusion Plates is HRS.

Related Clinical Trials

NCT06938607 Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement NOT_YET_RECRUITING NCT07231471 Platelet Rich Plasma for Musculoskeletal Conditions RECRUITING NCT03965143 Talus Replacement Registry RECRUITING NCT06829667 Retrospective Study of Suture Tape for Soft Tissue Reconstruction in Patients Suffering From Lateral Ankle Instability COMPLETED NCT06638138 Study of Artelon FLEXBAND® for Patients Undergoing Soft Tissue Reconstruction of the Anterior Talofibular Ligament (ATFL) to Treat Lateral Ankle Instability COMPLETED NCT06934629 Efficacy of Tecar Device With Exercises in Ankle Sprain COMPLETED

Other Devices by Osteomed

K161041OsteoMed ExtremiLOCK Wrist Plating System K162542OsteoMed PINNACLE Driver K162544OsteoMed PINNACLE Driver

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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