FDA 510(k)

Companion Spine DIAM Instrumentation

K-Number: K253118 · 2025-12-16

Decision Date2025-12-16

Product CodeQLR

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Companion Spine DIAM Instrumentation is a medical device manufactured by Companion Spine France. It received FDA 510(k) clearance on 2025-12-16 under approval number K253118. The device is classified under product code QLR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Companion Spine DIAM Instrumentation?

Companion Spine DIAM Instrumentation is a medical device that received FDA 510(k) clearance on 2025-12-16. It is manufactured by Companion Spine France. The 510(k) number is K253118.

When was Companion Spine DIAM Instrumentation approved by the FDA?

Companion Spine DIAM Instrumentation received FDA 510(k) clearance on 2025-12-16, under approval number K253118.

What company makes Companion Spine DIAM Instrumentation?

Companion Spine DIAM Instrumentation is manufactured by Companion Spine France.

What is the FDA product code for Companion Spine DIAM Instrumentation?

The FDA product code for Companion Spine DIAM Instrumentation is QLR.

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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.