FDA 510(k)

DualXSLIM(R) T/PLIF

K-Number: K222203 · 2022-10-18

Decision Date2022-10-18

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

DualXSLIM(R) T/PLIF is a medical device manufactured by Amplify Surgical, Inc.. It received FDA 510(k) clearance on 2022-10-18 under approval number K222203. 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 DualXSLIM(R) T/PLIF?

DualXSLIM(R) T/PLIF is a medical device that received FDA 510(k) clearance on 2022-10-18. It is manufactured by Amplify Surgical, Inc.. The 510(k) number is K222203.

When was DualXSLIM(R) T/PLIF approved by the FDA?

DualXSLIM(R) T/PLIF received FDA 510(k) clearance on 2022-10-18, under approval number K222203.

What company makes DualXSLIM(R) T/PLIF?

DualXSLIM(R) T/PLIF is manufactured by Amplify Surgical, Inc..

What is the FDA product code for DualXSLIM(R) T/PLIF?

The FDA product code for DualXSLIM(R) T/PLIF is MAX.

Other Devices by Amplify Surgical, Inc.

K192434DualX Lumbar Intervertebral Body Fusion Device K211740DualX

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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.