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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 a medical device manufactured by Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2019-11-07 under approval 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. It is manufactured by Synthes (USA) Products, LLC. The 510(k) number is K192327.

When was DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile approved by the FDA?

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

What company makes DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile?

DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile is manufactured by Synthes (USA) Products, LLC.

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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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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