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FDA 510(k)

ACP4 SPINAL IMPLANT SYSTEM

K-Number: K092360 · 2010-01-22

ApplicantX-Spine Systems, Inc.
Decision Date2010-01-22
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACP4 SPINAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is X-Spine Systems, Inc.. It received FDA 510(k) clearance on 2010-01-22 under 510(k) number K092360. 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 ACP4 SPINAL IMPLANT SYSTEM?

ACP4 SPINAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2010-01-22. The listed applicant is X-Spine Systems, Inc.. The 510(k) number is K092360.

When did ACP4 SPINAL IMPLANT SYSTEM receive FDA 510(k) clearance?

ACP4 SPINAL IMPLANT SYSTEM received FDA 510(k) clearance on 2010-01-22, under 510(k) number K092360.

Who is the listed applicant for ACP4 SPINAL IMPLANT SYSTEM?

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

What is the FDA product code for ACP4 SPINAL IMPLANT SYSTEM?

The FDA product code for ACP4 SPINAL IMPLANT SYSTEM is KWQ.

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Other records listing X-Spine Systems, Inc. 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.

K173832InTice™-C Porous Ti Cervical Interbody SystemK180153X-spine Cortical Bone Screw SystemK170119Calix Lumbar Spinal Implant SystemK171567IRIX-A Lumbar Integrated Fusion SystemK171075Calix-C Cervical Interbody SpacerK170224Spider Cervical Plating System

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Related Devices (Code: KWQ)

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.

K262149corra® cervical plating systemCarlsmed, Inc.K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC

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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