Pantheon Spinal Ibfd System

Q: What is the product code of K113781?

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) K113781 · Pantheon Spinal

Substantially Equivalent

510(k) numberK113781

Submission

Device name: Pantheon Spinal Ibfd System
Applicant: Pantheon Spinal
Austin, TX, US
Received: December 22, 2011
Decision date: April 26, 2013
Decision: Substantially Equivalent (SESE)
Type: Traditional 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.

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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
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K241494	Pantheon Pedicle Screw and Iliac Bolt Fixation SystemNKB · Traditional	07/26/2024SE
K203003	Pantheon IBFDMAX · Special	07/07/2021SE
K181548	Pantheon Spinal Pontus Interbody Fusion DeviceMAX · Traditional	12/16/2019SE

Questions and answers

When was Pantheon Spinal Ibfd System cleared by the FDA?

Pantheon Spinal Ibfd System (K113781) received a 510(k) decision of Substantially Equivalent on April 26, 2013, 491 days after the submission was received.

What is the product code of K113781?

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.