OVD · Intervertebral Fusion Device With Integrated Fixation, Lumbar

Orthopedic · 21 CFR 888.3080 · Class 2

Overview

Product CodeOVD
Device NameIntervertebral Fusion Device With Integrated Fixation, Lumbar
Regulation21 CFR 888.3080
Device ClassClass 2
Review PanelOrthopedic
ImplantYes

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Classification Rationale

(1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Recent Cleared Devices (20 of 200)

Showing 20 most recent of 200 cleared devices.

RecordDevice NameApplicantDecision DateDecision
K254202MectaLIF 3D Metal AnteriorMedacta International S.A.May 5, 2026SESE
K253401SCRIPT™ Implant SystemGlobus Medical, Inc.Apr 29, 2026SESE
K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.Feb 25, 2026SESE
K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen MedicalDec 8, 2025SESE
K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec SpineSep 3, 2025SESE
K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.Jul 10, 2025SESE
K251644ProAM ALIF SystemPro Surgical, Inc.Jun 24, 2025SESE
K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.Jun 18, 2025SESE
K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLCJun 12, 2025SESE
K243934Stable-L Lumbar Interbody SystemNexus Spine, LLCApr 30, 2025SESE
K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLCApr 22, 2025SESE
K250603AxTiHA® Stand-Alone ALIF SystemInnovasisMar 24, 2025SESE
K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.Mar 17, 2025SESE
K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.Dec 13, 2024SESE
K243191Atlas Spine Lateral Expandable Interbody SystemAtlas Spine, Inc.Nov 26, 2024SESE
K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen MedicalOct 29, 2024SESE
K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.Oct 28, 2024SESE
K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.Oct 9, 2024SESE
K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.Oct 2, 2024SESE
K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SAJul 18, 2024SESE

Top Applicants

Innolitics

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