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FDA 510(k)

MP Reconstruction System

K-Number: K213675 · 2022-04-11

Decision Date2022-04-11
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MP Reconstruction System is a medical device manufactured by Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2022-04-11 under approval number K213675. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MP Reconstruction System?

MP Reconstruction System is a medical device that received FDA 510(k) clearance on 2022-04-11. It is manufactured by Waldemar Link GmbH & Co. KG. The 510(k) number is K213675.

When was MP Reconstruction System approved by the FDA?

MP Reconstruction System received FDA 510(k) clearance on 2022-04-11, under approval number K213675.

What company makes MP Reconstruction System?

MP Reconstruction System is manufactured by Waldemar Link GmbH & Co. KG.

What is the FDA product code for MP Reconstruction System?

The FDA product code for MP Reconstruction System is LZO.

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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.