Vu Apod Intervertebral Body Fusion Device

Q: What is the product code of K101310?

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) K101310 · Theken Spine, LLC

Substantially Equivalent

510(k) numberK101310

Submission

Device name: Vu Apod Intervertebral Body Fusion Device
Applicant: Theken Spine, LLC
Washington, DC, US
Received: May 11, 2010
Decision date: September 2, 2010
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
K121482	Instrument System for Endoscopic Spinal SurgeryHRX · Traditional	08/28/2012SE
K121211	Vu Apod Intervertebral Body Fusion DeviceOVD · Special	06/27/2012SE
K120829	Stainless Steel Spinal SystemNKB · Special	05/30/2012SE
K120047	Coral Spinal SystemNKB · Special	02/03/2012SE
K111675	Vu C*Pod Intervertebral Body Fusion DeviceODP · Special	08/02/2011SE
K103228	Paramount R Ibf DeviceMAX · Special	01/05/2011SE
K102323	Cervical Standalone Intervertebral Body Fusion DeviceOVE · Traditional	12/16/2010SE
K100970	Stainless Steel Spinal SystemNKB · Traditional	08/12/2010SE
K091266	Theken Coral Spinal SystemNKB · Special	06/10/2009SE
K083863	Theken Atoll Oct Spinal SystemMNI · Traditional	03/27/2009SE

Questions and answers

When was Vu Apod Intervertebral Body Fusion Device cleared by the FDA?

Vu Apod Intervertebral Body Fusion Device (K101310) received a 510(k) decision of Substantially Equivalent on September 2, 2010, 114 days after the submission was received.

What is the product code of K101310?

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.