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FDA 510(k)

ADVANCE TOTAL KNEE SYSTEM

K-Number: K061223 · 2006-08-18

Decision Date2006-08-18
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ADVANCE TOTAL KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2006-08-18 under 510(k) number K061223. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVANCE TOTAL KNEE SYSTEM?

ADVANCE TOTAL KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2006-08-18. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K061223.

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

ADVANCE TOTAL KNEE SYSTEM received FDA 510(k) clearance on 2006-08-18, under 510(k) number K061223.

Who is the listed applicant for ADVANCE TOTAL KNEE SYSTEM?

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

What is the FDA product code for ADVANCE TOTAL KNEE SYSTEM?

The FDA product code for ADVANCE TOTAL KNEE SYSTEM is MBH.

Related Clinical Trials

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.

Other records listing Wrightmedicaltechnologyinc 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.

View all 268 devices →

Related Devices (Code: MBH)

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.

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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