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FDA 510(k)

PANTHEON SPINAL IBFD SYSTEM

K-Number: K113781 · 2013-04-26

ApplicantPantheon Spinal
Decision Date2013-04-26
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PANTHEON SPINAL IBFD SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pantheon Spinal. It received FDA 510(k) clearance on 2013-04-26 under 510(k) number K113781. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PANTHEON SPINAL IBFD SYSTEM?

PANTHEON SPINAL IBFD SYSTEM is a medical device that received FDA 510(k) clearance on 2013-04-26. The listed applicant is Pantheon Spinal. The 510(k) number is K113781.

When did PANTHEON SPINAL IBFD SYSTEM receive FDA 510(k) clearance?

PANTHEON SPINAL IBFD SYSTEM received FDA 510(k) clearance on 2013-04-26, under 510(k) number K113781.

Who is the listed applicant for PANTHEON SPINAL IBFD SYSTEM?

The FDA 510(k) record lists Pantheon Spinal as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PANTHEON SPINAL IBFD SYSTEM?

The FDA product code for PANTHEON SPINAL IBFD SYSTEM is MAX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Pantheon Spinal as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241494Pantheon Pedicle Screw and Iliac Bolt Fixation SystemK203003Pantheon IBFDK181548Pantheon Spinal Pontus Interbody Fusion Device

Related Devices (Code: MAX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261049SCALA® TLSpineart SAK261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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