Anteralign LS coverplate

Q: What is the product code of K260810?

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) K260810 · Tyber Medical, LLC

Substantially Equivalent

510(k) numberK260810

Submission

Device name: Anteralign LS coverplate
Applicant: Tyber Medical, LLC
Bethlehem, PA, US
Received: March 12, 2026
Decision date: June 10, 2026
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
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
K250072	CONDUIT SYNFIX Evolution Secured Spacer SystemOVD · Traditional	Avalign Technologies, Inc.	07/10/2025SE

More from Avalign Technologies, Inc.

510(k)	Device	Decision
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K253042	Tyber Medical Trauma ScrewHWC · Traditional	04/03/2026SE
K252901	Tyber Medical Trauma ScrewHWC · Traditional	12/31/2025SE
K252742	Navigated InstrumentsOLO · Traditional	10/28/2025SE
K251361	Tyber Medical Distal Radius Plating SystemHRS · Traditional	07/30/2025SE
K242486	Tyber Medical Anatomical Plating SystemHRS · Traditional	03/19/2025SE
K241218	Tyber Medical Anatomical Plating SystemHRS · Special	05/31/2024SE
K233423	Tyber Medical Anatomical Plating System Line extension to the Mini-Frag SystemHRS · Traditional	12/21/2023SE
K233017	TM Plating SystemHRS · Traditional	12/20/2023SE

Questions and answers

When was Anteralign LS coverplate cleared by the FDA?

Anteralign LS coverplate (K260810) received a 510(k) decision of Substantially Equivalent on June 10, 2026, 90 days after the submission was received.

What is the product code of K260810?

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.