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FDA 510(k)

Distal Elbow Plating System

K-Number: K171590 · 2017-06-27

ApplicantSkeletal Dynamics, LLC
Decision Date2017-06-27
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Distal Elbow Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Skeletal Dynamics, LLC. It received FDA 510(k) clearance on 2017-06-27 under 510(k) number K171590. 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 Distal Elbow Plating System?

Distal Elbow Plating System is a medical device that received FDA 510(k) clearance on 2017-06-27. The listed applicant is Skeletal Dynamics, LLC. The 510(k) number is K171590.

When did Distal Elbow Plating System receive FDA 510(k) clearance?

Distal Elbow Plating System received FDA 510(k) clearance on 2017-06-27, under 510(k) number K171590.

Who is the listed applicant for Distal Elbow Plating System?

The FDA 510(k) record lists Skeletal Dynamics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Distal Elbow Plating System?

The FDA product code for Distal Elbow Plating System is HRS.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07645768Is Anterior Reversed Proximal Humeral Locking Plate System (PHILOS) a Safe Alternative to Conventional Posterior Double Plating in Extra-Articular Distal Shaft Humeral FracturesACTIVE_NOT_RECRUITING

Other records listing Skeletal Dynamics, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261770Suture Button Repair SystemK254288Clavicle Fixation SystemK252949Geminus Volar Distal Radius Plating SystemK242436Proximal Humerus Fixation SystemK243381Total Wrist Arthroplasty System (TWA)K241815Protean Fragment Plating System

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Related Devices (Code: HRS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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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