FORZA XP Expandable Spacer System

Q: What is the product code of K213951?

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

FDA 510(k) K213951 · Orthofix US, LLC

Substantially Equivalent

510(k) numberK213951

Submission

Device name: FORZA XP Expandable Spacer System
Applicant: Orthofix US, LLC
Lewisville, TX, US
Received: December 17, 2021
Decision date: January 5, 2022
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

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

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other 510(k)s with product code MAX

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K253894	BMD Titanium Spinal Fusion SystemMAX · Traditional	Global Biomedica s.r.o.	05/28/2026SE
K260506	Ventana® P/T Lumbar Interbody SystemMAX · Traditional	Spinal Elements, Inc.	05/15/2026SE
K260837	VersaLift Expandable SystemMAX · Traditional	Life Spine, Inc.	05/12/2026SE

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Questions and answers

When was FORZA XP Expandable Spacer System cleared by the FDA?

FORZA XP Expandable Spacer System (K213951) received a 510(k) decision of Substantially Equivalent on January 5, 2022, 19 days after the submission was received.

What is the product code of K213951?

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