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FDA 510(k)

ASCENT KNEE SYSTEM

K-Number: K994326 · 2000-01-07

ApplicantBiomet Manufacturing, Inc.
Decision Date2000-01-07
Product CodeKWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ASCENT KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing, Inc.. It received FDA 510(k) clearance on 2000-01-07 under 510(k) number K994326. The device is classified under product code KWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASCENT KNEE SYSTEM?

ASCENT KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2000-01-07. The listed applicant is Biomet Manufacturing, Inc.. The 510(k) number is K994326.

When did ASCENT KNEE SYSTEM receive FDA 510(k) clearance?

ASCENT KNEE SYSTEM received FDA 510(k) clearance on 2000-01-07, under 510(k) number K994326.

Who is the listed applicant for ASCENT KNEE SYSTEM?

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

What is the FDA product code for ASCENT KNEE SYSTEM?

The FDA product code for ASCENT KNEE SYSTEM is KWH.

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Other records listing Biomet Manufacturing, Inc. as applicant

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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Related Devices (Code: KWH)

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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