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 the device name listed in this FDA 510(k) record. The listed applicant is Companion Spine France. It received FDA 510(k) clearance on 2025-12-16 under 510(k) 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. The listed applicant is Companion Spine France. The 510(k) number is K253118.

When did Companion Spine DIAM™ Instrumentation receive FDA 510(k) clearance?

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

Who is the listed applicant for Companion Spine DIAM™ Instrumentation?

The FDA 510(k) record lists Companion Spine France as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Companion Spine France as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P110008Prosthesis, spinous process spacer/plate

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.