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FDA 510(k)

Augment Off-Axis Instrument System

K-Number: K241043 · 2024-05-15

ApplicantFix Surgical
Decision Date2024-05-15
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Augment Off-Axis Instrument System is a medical device manufactured by Fix Surgical. It received FDA 510(k) clearance on 2024-05-15 under approval number K241043. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Augment Off-Axis Instrument System?

Augment Off-Axis Instrument System is a medical device that received FDA 510(k) clearance on 2024-05-15. It is manufactured by Fix Surgical. The 510(k) number is K241043.

When was Augment Off-Axis Instrument System approved by the FDA?

Augment Off-Axis Instrument System received FDA 510(k) clearance on 2024-05-15, under approval number K241043.

What company makes Augment Off-Axis Instrument System?

Augment Off-Axis Instrument System is manufactured by Fix Surgical.

What is the FDA product code for Augment Off-Axis Instrument System?

The FDA product code for Augment Off-Axis Instrument System is PHX.

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Other Devices by Fix Surgical

K233148Augment Off-Axis Instrument System

Related Devices (Code: PHX)

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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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