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FDA 510(k)

Augment Off-Axis Instrument System

K-Number: K261683 · 2026-06-16

ApplicantZimmer, Inc.
Decision Date2026-06-16
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Augment Off-Axis Instrument System is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2026-06-16 under 510(k) number K261683. 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 2026-06-16. The listed applicant is Zimmer, Inc.. The 510(k) number is K261683.

When did Augment Off-Axis Instrument System receive FDA 510(k) clearance?

Augment Off-Axis Instrument System received FDA 510(k) clearance on 2026-06-16, under 510(k) number K261683.

Who is the listed applicant for Augment Off-Axis Instrument System?

The FDA 510(k) record lists Zimmer, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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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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