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FDA 510(k)

NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System

K-Number: K163425 · 2017-03-24

ApplicantNarang Medical USA Corporation
Decision Date2017-03-24
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System is a medical device manufactured by Narang Medical USA Corporation. It received FDA 510(k) clearance on 2017-03-24 under approval number K163425. 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 NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System?

NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System is a medical device that received FDA 510(k) clearance on 2017-03-24. It is manufactured by Narang Medical USA Corporation. The 510(k) number is K163425.

When was NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System approved by the FDA?

NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System received FDA 510(k) clearance on 2017-03-24, under approval number K163425.

What company makes NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System?

NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System is manufactured by Narang Medical USA Corporation.

What is the FDA product code for NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System?

The FDA product code for NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System is HRS.

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Related PubMed Literature

PMID: 33371797 Developing a Qualification and Verification Strategy for Digital Tissue Image Analysis in Toxicological Pathology. Toxicologic pathology (2021) PMID: 31926779 Pigtail Catheter Insertion Error: Root Cause Analysis and Recommendations for Patient Safety. The Journal of emergency medicine (2020) PMID: 30115367 The multiple arrhythmia dataset evaluation database (M.A.D.A.E.). Journal of electrocardiology (2018)

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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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