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FDA 510(k)

DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long

K-Number: K163046 · 2017-02-09

ApplicantDePuy Synthes
Decision Date2017-02-09
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Synthes. It received FDA 510(k) clearance on 2017-02-09 under 510(k) number K163046. 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 DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long?

DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long is a medical device that received FDA 510(k) clearance on 2017-02-09. The listed applicant is DePuy Synthes. The 510(k) number is K163046.

When did DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long receive FDA 510(k) clearance?

DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long received FDA 510(k) clearance on 2017-02-09, under 510(k) number K163046.

Who is the listed applicant for DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long?

The FDA 510(k) record lists DePuy Synthes as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long?

The FDA product code for DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long is HRS.

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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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