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Cutting Edge Spine Interbody Fusion Device

FDA 510(k)

Class II (US FDA 510(k))

510(k) K102957

by Cutting Edge Spine, LLC

Identifiers

510(k) Number
K102957 FDA 510(k)
FDA Product Code
MAX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3080 FDA 510(k)
Regulation Number
888.3080 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Cutting Edge Spine Interbody Fusion Device is classified as an intervertebral body device designed for spinal fusion procedures. It is intended to provide structural support and promote bony fusion in the lumbar spine, addressing degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2 to S1.

This device is supplied as a single-use implant and is regulated under FDA 510(k) clearance (K102957) as substantially equivalent to a predicate device. It is intended for use in skeletally mature patients and is distributed by Cutting Edge Spine, LLC. No additional sterility or MRI safety specifications are stated in the provided data.

Frequently asked questions

What spinal conditions is this device specifically designed to address and at which levels of the lumbar spine can it be used?

This device is designed for spinal fusion procedures to address degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. It is intended for use at one or two contiguous levels from L2 to S1 in the lumbar spine, providing structural support and promoting bony fusion.

Is this device intended for reuse or is it meant to be used only once?

The Cutting Edge Spine Interbody Fusion Device is explicitly supplied as a single-use implant, meaning it is not intended for reuse after a single surgical procedure.

What type of regulatory clearance does this device hold, and how does it compare to other spinal implants?

This device holds FDA 510(k) clearance (K102957) and is classified as substantially equivalent to a predicate device. The clearance was granted under the Traditional review pathway by the Orthopedic (OR) Advisory Committee, confirming its compliance with FDA standards for interbody fusion implants.

Are there any specific patient criteria mentioned for using this device?

The device is intended only for skeletally mature patients, meaning it is not approved for use in children or adolescents whose bones are still developing.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CUTTING EDGE SPINE INTERBODY FUSION DEVICE (K102957) — FDA 510 (k ..., Spinal Implant Systems | Cutting Edge Spine, EVOSha | Interbody System | Cutting Edge Spine

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cutting Edge Spine, LLC

Sources (1)

  • FDA 510(k) K102957 24 fields · synced Sep 19, 2026