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FDA 510(k)

WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER

K-Number: K980496 · 1998-04-14

ApplicantWrightmedicaltechnologyinc
Decision Date1998-04-14
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 1998-04-14 under 510(k) number K980496. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER?

WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER is a medical device that received FDA 510(k) clearance on 1998-04-14. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K980496.

When did WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER receive FDA 510(k) clearance?

WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER received FDA 510(k) clearance on 1998-04-14, under 510(k) number K980496.

Who is the listed applicant for WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER?

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

What is the FDA product code for WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER?

The FDA product code for WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER is MNH. This falls under the ENT category.

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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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