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FDA 510(k)

Titanium TomoFix Medial High Tibia Plate Anatomical

K-Number: K180213 · 2018-10-19

ApplicantSynthes (USA) Products, LLC
Decision Date2018-10-19
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Titanium TomoFix Medial High Tibia Plate Anatomical is a medical device manufactured by Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2018-10-19 under approval number K180213. 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 Titanium TomoFix Medial High Tibia Plate Anatomical?

Titanium TomoFix Medial High Tibia Plate Anatomical is a medical device that received FDA 510(k) clearance on 2018-10-19. It is manufactured by Synthes (USA) Products, LLC. The 510(k) number is K180213.

When was Titanium TomoFix Medial High Tibia Plate Anatomical approved by the FDA?

Titanium TomoFix Medial High Tibia Plate Anatomical received FDA 510(k) clearance on 2018-10-19, under approval number K180213.

What company makes Titanium TomoFix Medial High Tibia Plate Anatomical?

Titanium TomoFix Medial High Tibia Plate Anatomical is manufactured by Synthes (USA) Products, LLC.

What is the FDA product code for Titanium TomoFix Medial High Tibia Plate Anatomical?

The FDA product code for Titanium TomoFix Medial High Tibia Plate Anatomical is HRS.

Related Clinical Trials

NCT07608380 Accuracy of Positioning Guide and Customized Plate in Zygomaticomaxillary Complex Fractures ENROLLING_BY_INVITATION NCT06622512 Two Standardized Radial Pressure Wave Techniques Versus Pain-Site Guided Therapy in Patients With Knee Osteoarthritis. COMPLETED NCT07574554 Fixation of Mandibular Angle Fracture Using 3D Titanium Miniplate Versus Standard Two Plate Fixation ACTIVE_NOT_RECRUITING NCT07520227 Comparative Evaluation of 3D-printed (PEEK) Plates Versus Titanium 3D Plate for Fracture Fixation at the Mandibular Angle COMPLETED

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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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