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FDA 510(k)

THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0

K-Number: K012866 · 2001-09-26

ApplicantImplex Corp.
Decision Date2001-09-26
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0 is the device name listed in this FDA 510(k) record. The listed applicant is Implex Corp.. It received FDA 510(k) clearance on 2001-09-26 under 510(k) number K012866. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0?

THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0 is a medical device that received FDA 510(k) clearance on 2001-09-26. The listed applicant is Implex Corp.. The 510(k) number is K012866.

When did THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0 receive FDA 510(k) clearance?

THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0 received FDA 510(k) clearance on 2001-09-26, under 510(k) number K012866.

Who is the listed applicant for THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0?

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

What is the FDA product code for THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0?

The FDA product code for THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0 is JWH.

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Other records listing Implex Corp. as applicant

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Related Devices (Code: JWH)

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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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