FDA 510(k)

“BioGend” Interbody Fusion System 001 Cage

Numéro K : K233075 · 2024-03-06

Date de décision2024-03-06

Code produitMAX

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

“BioGend” Interbody Fusion System 001 Cage is the device name listed in this FDA 510(k) record. The listed applicant is Biogend Therapeutics Co., Ltd.. It received FDA 510(k) clearance on 2024-03-06 under 510(k) number K233075. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the “BioGend” Interbody Fusion System 001 Cage?

“BioGend” Interbody Fusion System 001 Cage is a medical device that received FDA 510(k) clearance on 2024-03-06. The listed applicant is Biogend Therapeutics Co., Ltd.. The 510(k) number is K233075.

When did “BioGend” Interbody Fusion System 001 Cage receive FDA 510(k) clearance?

“BioGend” Interbody Fusion System 001 Cage received FDA 510(k) clearance on 2024-03-06, under 510(k) number K233075.

Who is the listed applicant for “BioGend” Interbody Fusion System 001 Cage?

The FDA 510(k) record lists Biogend Therapeutics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for “BioGend” Interbody Fusion System 001 Cage?

The FDA product code for “BioGend” Interbody Fusion System 001 Cage is MAX.

Essais cliniques associés

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Dispositifs connexes (Code : MAX)

K261049SCALA® TLSpineart SA 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 Corporation K253151Système de Cage de Fusion Intervertébral FuleBeijing Fule Science & Technology Development Co., Ltd.

Source officielle

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