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FDA 510(k)

AXLE INTERSPINOUS FUSION SYSTEM

K-Number: K130438 · 2013-06-27

ApplicantX-Spine Systems, Inc.
Decision Date2013-06-27
Product CodePEK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AXLE INTERSPINOUS FUSION 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 2013-06-27 under 510(k) number K130438. The device is classified under product code PEK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXLE INTERSPINOUS FUSION SYSTEM?

AXLE INTERSPINOUS FUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2013-06-27. The listed applicant is X-Spine Systems, Inc.. The 510(k) number is K130438.

When did AXLE INTERSPINOUS FUSION SYSTEM receive FDA 510(k) clearance?

AXLE INTERSPINOUS FUSION SYSTEM received FDA 510(k) clearance on 2013-06-27, under 510(k) number K130438.

Who is the listed applicant for AXLE INTERSPINOUS FUSION 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 AXLE INTERSPINOUS FUSION SYSTEM?

The FDA product code for AXLE INTERSPINOUS FUSION SYSTEM is PEK.

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Other records listing X-Spine Systems, Inc. as applicant

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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: PEK)

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.

K253250Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLCK234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3Spinal Simplicity, LLCK233527Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLCK232484KeyLift™ Expandable Interlaminar Stabilization SystemFlospineK231807primaLOK™ SP Interspinous Fusion SystemWenzel Spine, Inc.K223790Huvex Interspinous Fusion SystemDio Medical Corp.

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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