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FDA 510(k)

DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile

K-Number: K192327 · 2019-11-07

ApplicantSynthes (USA) Products, LLC
Decision Date2019-11-07
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2019-11-07 under 510(k) number K192327. 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 2.4mm LCP Straight Wrist Plate, Sterile?

DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile is a medical device that received FDA 510(k) clearance on 2019-11-07. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K192327.

When did DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile receive FDA 510(k) clearance?

DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile received FDA 510(k) clearance on 2019-11-07, under 510(k) number K192327.

Who is the listed applicant for DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile?

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

What is the FDA product code for DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile?

The FDA product code for DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile is HRS.

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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.

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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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