ENZA Zero-Profile Anterior Interbody Fusion

Q: What is the product code of K153720?

The FDA product code is OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.

FDA 510(k) K153720 · Camber Spine Technologies

Substantially Equivalent

510(k) numberK153720

Submission

Device name: ENZA Zero-Profile Anterior Interbody Fusion
Applicant: Camber Spine Technologies
Wayne, PA, US
Received: December 28, 2015
Decision date: May 3, 2016
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3080
Specialty: Orthopedic
Implant: Yes

Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

Other 510(k)s with product code OVD

510(k)	Device	Applicant	Decision
K262025	Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…OVD · Traditional	INNO Holdings Inc. DBA Innovasis	09/11/2026SE
K261408	SABER-XA SystemOVD · Traditional	Elevation Spine	08/03/2026SE
K261809	Interwedge® Standalone LateralOVD · Special	Foundation Surgical Group	07/31/2026SE
K261353	Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…OVD · Traditional	Kyocera Medical Technologies, Inc.	07/15/2026SE
K260810	Anteralign LS coverplateOVD · Traditional	Tyber Medical, LLC	06/10/2026SE
K254202	MectaLIF 3D Metal AnteriorOVD · Traditional	Medacta International S.A.	05/05/2026SE
K253401	SCRIPT Implant SystemOVD · Traditional	Globus Medical, Inc.	04/29/2026SE
K253559	Ventana A Anterior Lumbar Interbody SystemOVD · Traditional	Spinal Elements, Inc.	02/25/2026SE
K251829	DeGen Medical Patient Specific Implant (PSI) SystemOVD · Traditional	Degen Medical	12/08/2025SE
K251575	IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody SystemOVD · Traditional	Alphatec Spine	09/03/2025SE

More from Alphatec Spine

510(k)	Device	Decision
K234077	SPIRA® Anterior Lumbar SpacersMAX · Traditional	07/12/2024SE
K232256	Alcantara Thoracolumbar Plate SystemKWQ · Traditional	04/16/2024SE
K233972	Camber Sacroiliac (SI) Fixation SystemOUR · Traditional	02/27/2024SE
K230942	SPIRA® Posterior Lumbar SpacersMAX · Traditional	07/11/2023SE
K221324	ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)OVD · Traditional	03/30/2023SE
K223837	SPIRA®-C Integrated Fixation SystemOVE · Traditional	03/22/2023SE
K203503	Camber Sacroiliac (SI) Fixation SystemOUR · Traditional	09/02/2022SE
K220038	Camber Spine Navigation SystemOLO · Traditional	04/29/2022SE
K210595	SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersMAX · Traditional	06/15/2021SE
K193153	SPIRA-C Integrated Fixation SystemOVE · Traditional	04/24/2020SE

Questions and answers

When was ENZA Zero-Profile Anterior Interbody Fusion cleared by the FDA?

ENZA Zero-Profile Anterior Interbody Fusion (K153720) received a 510(k) decision of Substantially Equivalent on May 3, 2016, 127 days after the submission was received.

What is the product code of K153720?

The FDA product code is OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.