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FDA 510(k)

Pantheon IBFD

K-Number: K203003 · 2021-07-07

ApplicantPantheon Spinal
Decision Date2021-07-07
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Pantheon IBFD is the device name listed in this FDA 510(k) record. The listed applicant is Pantheon Spinal. It received FDA 510(k) clearance on 2021-07-07 under 510(k) number K203003. 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 IBFD?

Pantheon IBFD is a medical device that received FDA 510(k) clearance on 2021-07-07. The listed applicant is Pantheon Spinal. The 510(k) number is K203003.

When did Pantheon IBFD receive FDA 510(k) clearance?

Pantheon IBFD received FDA 510(k) clearance on 2021-07-07, under 510(k) number K203003.

Who is the listed applicant for Pantheon IBFD?

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 IBFD?

The FDA product code for Pantheon IBFD is MAX.

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 SystemK181548Pantheon 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.

K261430TruLift 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.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.

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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