Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Skeletal Dynamics Ulnar Shortening Plating System

K-Number: K201962 · 2020-10-13

ApplicantSkeletal Dynamics, Inc.
Decision Date2020-10-13
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Skeletal Dynamics Ulnar Shortening Plating System is a medical device manufactured by Skeletal Dynamics, Inc.. It received FDA 510(k) clearance on 2020-10-13 under approval number K201962. 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 Skeletal Dynamics Ulnar Shortening Plating System?

Skeletal Dynamics Ulnar Shortening Plating System is a medical device that received FDA 510(k) clearance on 2020-10-13. It is manufactured by Skeletal Dynamics, Inc.. The 510(k) number is K201962.

When was Skeletal Dynamics Ulnar Shortening Plating System approved by the FDA?

Skeletal Dynamics Ulnar Shortening Plating System received FDA 510(k) clearance on 2020-10-13, under approval number K201962.

What company makes Skeletal Dynamics Ulnar Shortening Plating System?

Skeletal Dynamics Ulnar Shortening Plating System is manufactured by Skeletal Dynamics, Inc..

What is the FDA product code for Skeletal Dynamics Ulnar Shortening Plating System?

The FDA product code for Skeletal Dynamics Ulnar Shortening Plating System is HRS.

Related Clinical Trials

NCT00453505 Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System COMPLETED NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING NCT05183152 Non-invasive BCI-controlled Assistive Devices RECRUITING NCT07387419 Ultradian Steroid Rhythms in Adrenal Incidentalomas RECRUITING NCT07534150 Blood Flow Restriction Parameters and Lower Limb Function in Older Adults With Dynapenia NOT_YET_RECRUITING NCT07528950 Impact médico-économique de la télésurveillance Des Plaies Chroniques Avec Pixacare NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026)

Other Devices by Skeletal Dynamics, Inc.

K201662REDUCT® Headless Compression Screw System K200538Skeletal Dynamics Forearm Plating System K200701Skeletal Dynamics Midshaft Humerus Plating System K200367Distal Humerus Plating System K211439Small Bone Nailing System K220723Hand Trauma Screw System

View all 20 devices →

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.

↑