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FDA 510(k)

OsteoMed ExtremiLOCK Wrist Plating System

K-Number: K161041 · 2016-05-19

ApplicantOsteomed
Decision Date2016-05-19
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OsteoMed ExtremiLOCK Wrist Plating System is a medical device manufactured by Osteomed. It received FDA 510(k) clearance on 2016-05-19 under approval number K161041. 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 OsteoMed ExtremiLOCK Wrist Plating System?

OsteoMed ExtremiLOCK Wrist Plating System is a medical device that received FDA 510(k) clearance on 2016-05-19. It is manufactured by Osteomed. The 510(k) number is K161041.

When was OsteoMed ExtremiLOCK Wrist Plating System approved by the FDA?

OsteoMed ExtremiLOCK Wrist Plating System received FDA 510(k) clearance on 2016-05-19, under approval number K161041.

What company makes OsteoMed ExtremiLOCK Wrist Plating System?

OsteoMed ExtremiLOCK Wrist Plating System is manufactured by Osteomed.

What is the FDA product code for OsteoMed ExtremiLOCK Wrist Plating System?

The FDA product code for OsteoMed ExtremiLOCK Wrist Plating System is HRS.

Related Clinical Trials

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.