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InFill Interbody Fusion Devices

FDA 510(k)

Class II (US FDA 510(k))

510(k) K151184

by Pinnacle Spine Group, Llc

Identifiers

510(k) Number
K151184 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)

InFill Interbody Fusion Devices are intervertebral body fusion devices indicated for use in skeletally mature patients. These devices are designed for spinal fusion procedures to promote bone growth between vertebrae.

The devices are supplied non-sterile and intended for single-use. They are used in surgical settings for lumbar interbody fusion and have received FDA 510(k) clearance under product code MAX, with clearance granted on July 14, 2015.

Frequently asked questions

What is the InFill Interbody Fusion Device used for?

The InFill Interbody Fusion Device is indicated for use in skeletally mature patients undergoing spinal fusion procedures to promote bone growth between vertebrae, specifically for lumbar interbody fusion.

How is the InFill Interbody Fusion Device supplied and is it reusable?

The device is supplied non-sterile and is intended for single-use only; it must not be reprocessed or reused after surgical use to ensure patient safety and device integrity.

What regulatory pathway was used for the InFill Interbody Fusion Device?

The InFill Interbody Fusion Device received FDA 510(k) clearance under product code MAX, with the submission number K151184 and clearance granted on July 14, 2015, based on a traditional review process.

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: Home - Pinnacle Spine Group, InFill V2 Lateral Implant - Pinnacle Spine Group, InFill Interbody Fusion Devices by PINNACLE SPINE GROUP, LLC | FDA 510 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pinnacle Spine Group, Llc

Sources (1)

  • FDA 510(k) K151184 24 fields · synced Oct 1, 2026