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FDA 510(k)

Frida™ Anterior Cervical Plate System

K-Number: K250446 · 2025-05-23

ApplicantSpineup, Inc.
Decision Date2025-05-23
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Frida™ Anterior Cervical Plate System is a medical device manufactured by Spineup, Inc.. It received FDA 510(k) clearance on 2025-05-23 under approval number K250446. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Frida™ Anterior Cervical Plate System?

Frida™ Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2025-05-23. It is manufactured by Spineup, Inc.. The 510(k) number is K250446.

When was Frida™ Anterior Cervical Plate System approved by the FDA?

Frida™ Anterior Cervical Plate System received FDA 510(k) clearance on 2025-05-23, under approval number K250446.

What company makes Frida™ Anterior Cervical Plate System?

Frida™ Anterior Cervical Plate System is manufactured by Spineup, Inc..

What is the FDA product code for Frida™ Anterior Cervical Plate System?

The FDA product code for Frida™ Anterior Cervical Plate System is KWQ.

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Other Devices by Spineup, Inc.

K212358Romero Cervical Cage

Related Devices (Code: KWQ)

K160982Sphynx™Eden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, Inc.

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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