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FDA 510(k)

ADVANCE TOTAL KNEE SYSTEM-PATELLA

K-Number: K122218 · 2013-03-21

ApplicantWrightmedicaltechnologyinc
Decision Date2013-03-21
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ADVANCE TOTAL KNEE SYSTEM-PATELLA is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2013-03-21 under 510(k) number K122218. 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-PATELLA?

ADVANCE TOTAL KNEE SYSTEM-PATELLA is a medical device that received FDA 510(k) clearance on 2013-03-21. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K122218.

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

ADVANCE TOTAL KNEE SYSTEM-PATELLA received FDA 510(k) clearance on 2013-03-21, under 510(k) number K122218.

Who is the listed applicant for ADVANCE TOTAL KNEE SYSTEM-PATELLA?

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-PATELLA?

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

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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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