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FDA 510(k)

TRONZO HIP

K-Number: K812946 · 1981-11-06

ApplicantBiomet, Inc.
Decision Date1981-11-06
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRONZO HIP is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1981-11-06 under 510(k) number K812946. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRONZO HIP?

TRONZO HIP is a medical device that received FDA 510(k) clearance on 1981-11-06. The listed applicant is Biomet, Inc.. The 510(k) number is K812946.

When did TRONZO HIP receive FDA 510(k) clearance?

TRONZO HIP received FDA 510(k) clearance on 1981-11-06, under 510(k) number K812946.

Who is the listed applicant for TRONZO HIP?

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 TRONZO HIP?

The FDA product code for TRONZO HIP is DXQ.

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Other records listing Biomet, Inc. as applicant

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Related Devices (Code: DXQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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