FDA 510(k)

Pantheon IBFD

K-Number: K203003 · 2021-07-07

Decision Date2021-07-07

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Pantheon IBFD is a medical device manufactured by Pantheon Spinal. It received FDA 510(k) clearance on 2021-07-07 under approval number K203003. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pantheon IBFD?

Pantheon IBFD is a medical device that received FDA 510(k) clearance on 2021-07-07. It is manufactured by Pantheon Spinal. The 510(k) number is K203003.

When was Pantheon IBFD approved by the FDA?

Pantheon IBFD received FDA 510(k) clearance on 2021-07-07, under approval number K203003.

What company makes Pantheon IBFD?

Pantheon IBFD is manufactured by Pantheon Spinal.

What is the FDA product code for Pantheon IBFD?

The FDA product code for Pantheon IBFD is MAX.

Other Devices by Pantheon Spinal

K181548Pantheon Spinal Pontus Interbody Fusion Device K241494Pantheon Pedicle Screw and Iliac Bolt Fixation System

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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.