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FDA 510(k)

TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM

K-Number: K090024 · 2009-05-04

ApplicantAlexandria Research Technologies, LLC
Decision Date2009-05-04
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Alexandria Research Technologies, LLC. It received FDA 510(k) clearance on 2009-05-04 under 510(k) number K090024. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM?

TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM is a medical device that received FDA 510(k) clearance on 2009-05-04. The listed applicant is Alexandria Research Technologies, LLC. The 510(k) number is K090024.

When did TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM receive FDA 510(k) clearance?

TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM received FDA 510(k) clearance on 2009-05-04, under 510(k) number K090024.

Who is the listed applicant for TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM?

The FDA 510(k) record lists Alexandria Research Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM?

The FDA product code for TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM is HSX.

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Other records listing Alexandria Research Technologies, LLC 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.

K101206TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY (TGS UKA) MODULAR TIBIA SYSTEM

Related Devices (Code: HSX)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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