Pantheon Pedicle Screw and Iliac Bolt Fixation System

FDA 510(k) K241494 · Pantheon Spinal

Substantially Equivalent

510(k) numberK241494

Submission

Device name
Pantheon Pedicle Screw and Iliac Bolt Fixation System
Applicant
Pantheon Spinal
Georgetown, TX, US
Received
May 28, 2024
Decision date
July 26, 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
NKB – Thoracolumbosacral Pedicle Screw System
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3070
Specialty
Orthopedic
Implant
Yes

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

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K253802KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special S.M.A.I.O07/01/2026SE
K253045“Socko” Vimax Spinal Fixation SystemNKB · Traditional Socko Medical Co., Ltd.06/17/2026SE
K251251ChanPin Pedicle Screw Spinal SystemNKB · Traditional Chanpin Medtak Co., Ltd.06/09/2026SE
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K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…NKB · Traditional Globus Medical, Inc.05/07/2026SE
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More from L&K BIOMED Co., Ltd.

510(k)DeviceDecision
K203003Pantheon IBFDMAX · Special 07/07/2021SE
K181548Pantheon Spinal Pontus Interbody Fusion DeviceMAX · Traditional 12/16/2019SE
K113781Pantheon Spinal Ibfd SystemMAX · Traditional 04/26/2013SE

Questions and answers

When was Pantheon Pedicle Screw and Iliac Bolt Fixation System cleared by the FDA?

Pantheon Pedicle Screw and Iliac Bolt Fixation System (K241494) received a 510(k) decision of Substantially Equivalent on July 26, 2024, 59 days after the submission was received.

What is the product code of K241494?

The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.