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FDA 510(k)

POWER TEK II

K-Number: K020761 · 2002-04-03

ApplicantBiomet, Inc.
Decision Date2002-04-03
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

POWER TEK II is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2002-04-03 under 510(k) number K020761. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWER TEK II?

POWER TEK II is a medical device that received FDA 510(k) clearance on 2002-04-03. The listed applicant is Biomet, Inc.. The 510(k) number is K020761.

When did POWER TEK II receive FDA 510(k) clearance?

POWER TEK II received FDA 510(k) clearance on 2002-04-03, under 510(k) number K020761.

Who is the listed applicant for POWER TEK II?

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

What is the FDA product code for POWER TEK II?

The FDA product code for POWER TEK II is HRX.

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Related Devices (Code: HRX)

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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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