aprevo® anterior lumbar interbody fusion device with interfixation

Q: What is the product code of K241477?

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) K241477 · Carlsmed, Inc.

Substantially Equivalent

510(k) numberK241477

Submission

Device name: aprevo® anterior lumbar interbody fusion device with interfixation
Applicant: Carlsmed, Inc.
Carlsbad, CA, US
Received: May 24, 2024
Decision date: October 9, 2024
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.

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More from Alphatec Spine

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K252611	aprevo® cervical plating systemKWQ · Traditional	12/22/2025SE
K250827	aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…MAX · Traditional	07/07/2025SE
K250987	aprevo® posterior/transforaminal lumbar interbody fusion deviceMAX · Traditional	06/30/2025SE
K243802	aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…OVD · Traditional	03/17/2025SE
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K243635	aprevo® anterior lumbar interbody fusion device with interfixationOVD · Special	12/13/2024SE
K242260	aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMODP · Traditional	11/15/2024SE

Questions and answers

When was aprevo® anterior lumbar interbody fusion device with interfixation cleared by the FDA?

aprevo® anterior lumbar interbody fusion device with interfixation (K241477) received a 510(k) decision of Substantially Equivalent on October 9, 2024, 138 days after the submission was received.

What is the product code of K241477?

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.