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Spineolgy Peek Bullet Lumber Interbody Fusion Device

FDA 510(k)

Class II (US FDA 510(k))

510(k) K111880

by Spineology Inc.

Identifiers

510(k) Number
K111880 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 Spineology PEEK Bullet Lumbar Interbody Fusion Device is an intervertebral body fusion device. It is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s).

The device is supplied as a single implant and may be used for multiple lumbar fusion approaches, including open, MIS TLIF, ultra-MIS (OptiLIF), and endoscopic fusion (OptiLIF Endo) applications. It received FDA 510(k) clearance under K111880 with product code MAX and was determined to be substantially equivalent. The device is manufactured by Spineology, Inc. and is intended for use in the lumbar spine as specified in its labeling.

Frequently asked questions

What is the Spineology PEEK Bullet Lumbar Interbody Fusion Device used for?

It is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s), as stated in its labeling.

How is the Spineology PEEK Bullet Lumbar Interbody Fusion Device supplied?

The device is supplied as a single implant and may be used for multiple lumbar fusion approaches, including open, MIS TLIF, ultra-MIS (OptiLIF), and endoscopic fusion (OptiLIF Endo) applications.

What regulatory pathway was used for the Spineology PEEK Bullet Lumbar Interbody Fusion Device?

The device received FDA 510(k) clearance under K111880 with product code MAX and was determined to be substantially equivalent to a predicate device.

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: Spineology Peek Bullet Lumbar Interbody Fusion Device, Spineology, SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE by SPINEOLOGY, INC ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Spineology Inc.
FDA Applicant
Spineology, Inc.

Sources (1)

  • FDA 510(k) K111880 24 fields · synced Oct 1, 2026