Tyber Medical Distal Radius Plating System
K-Number: K232693 · 2023-12-04
ApplicantTyber Medical, LLC
Decision Date2023-12-04
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Tyber Medical Distal Radius Plating System is a medical device manufactured by Tyber Medical, LLC. It received FDA 510(k) clearance on 2023-12-04 under approval number K232693. 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 Tyber Medical Distal Radius Plating System?
Tyber Medical Distal Radius Plating System is a medical device that received FDA 510(k) clearance on 2023-12-04. It is manufactured by Tyber Medical, LLC. The 510(k) number is K232693.
When was Tyber Medical Distal Radius Plating System approved by the FDA?
Tyber Medical Distal Radius Plating System received FDA 510(k) clearance on 2023-12-04, under approval number K232693.
What company makes Tyber Medical Distal Radius Plating System?
Tyber Medical Distal Radius Plating System is manufactured by Tyber Medical, LLC.
What is the FDA product code for Tyber Medical Distal Radius Plating System?
The FDA product code for Tyber Medical Distal Radius Plating System is HRS.
Related Clinical Trials
NCT01143558
Searching for Persistence of Infection in Lyme Disease
COMPLETED
NCT07137455
EDEN Intracardiac Electrogram Recording and Classifying System
ENROLLING_BY_INVITATION
NCT01174108
Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells
RECRUITING
NCT03280862
DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS
COMPLETED
NCT05701917
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
RECRUITING
NCT05754281
The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System
ACTIVE_NOT_RECRUITING
Related PubMed Literature
PMID: 42175114
Make Open Source Compliant: Validation in Non-Interventional Clinical Studies.
Studies in health technology and informatics (2026)
PMID: 42174947
Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks.
Studies in health technology and informatics (2026)
PMID: 42056377
Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh.
Scientific reports (2026)
PMID: 41879133
Medical Device Regulation - Who Does the FDA Serve?
The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)
Other Devices by Tyber Medical, LLC
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.