FDA 510(k)

MaxTack Motorized Fixation Device

K-Number: K231240 · 2023-09-08

Decision Date2023-09-08

Product CodeOCW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

MaxTack Motorized Fixation Device is a medical device manufactured by Covidien. It received FDA 510(k) clearance on 2023-09-08 under approval number K231240. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MaxTack Motorized Fixation Device?

MaxTack Motorized Fixation Device is a medical device that received FDA 510(k) clearance on 2023-09-08. It is manufactured by Covidien. The 510(k) number is K231240.

When was MaxTack Motorized Fixation Device approved by the FDA?

MaxTack Motorized Fixation Device received FDA 510(k) clearance on 2023-09-08, under approval number K231240.

What company makes MaxTack Motorized Fixation Device?

MaxTack Motorized Fixation Device is manufactured by Covidien.

What is the FDA product code for MaxTack Motorized Fixation Device?

The FDA product code for MaxTack Motorized Fixation Device is OCW.

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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.