FDA 510(k)

Born PT-LIF Cage HA

K-Number: K202380 · 2021-02-19

Decision Date2021-02-19

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Born PT-LIF Cage HA is a medical device manufactured by Spineworxx AG. It received FDA 510(k) clearance on 2021-02-19 under approval number K202380. 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 Born PT-LIF Cage HA?

Born PT-LIF Cage HA is a medical device that received FDA 510(k) clearance on 2021-02-19. It is manufactured by Spineworxx AG. The 510(k) number is K202380.

When was Born PT-LIF Cage HA approved by the FDA?

Born PT-LIF Cage HA received FDA 510(k) clearance on 2021-02-19, under approval number K202380.

What company makes Born PT-LIF Cage HA?

Born PT-LIF Cage HA is manufactured by Spineworxx AG.

What is the FDA product code for Born PT-LIF Cage HA?

The FDA product code for Born PT-LIF Cage HA is MAX.

Related Devices (Code: MAX)

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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.