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FDA 510(k)

iTotal Family Reusable Instrument Tray

K-Number: K170226 · 2017-10-25

ApplicantConformis, Inc.
Decision Date2017-10-25
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

iTotal Family Reusable Instrument Tray is a medical device manufactured by Conformis, Inc.. It received FDA 510(k) clearance on 2017-10-25 under approval number K170226. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iTotal Family Reusable Instrument Tray?

iTotal Family Reusable Instrument Tray is a medical device that received FDA 510(k) clearance on 2017-10-25. It is manufactured by Conformis, Inc.. The 510(k) number is K170226.

When was iTotal Family Reusable Instrument Tray approved by the FDA?

iTotal Family Reusable Instrument Tray received FDA 510(k) clearance on 2017-10-25, under approval number K170226.

What company makes iTotal Family Reusable Instrument Tray?

iTotal Family Reusable Instrument Tray is manufactured by Conformis, Inc..

What is the FDA product code for iTotal Family Reusable Instrument Tray?

The FDA product code for iTotal Family Reusable Instrument Tray is KCT.

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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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