FDA 510(k)

PathLoc Lumbar Interbody Fusion Cage System

Número K: K251741 · 2025-07-08

Data da decisão2025-07-08

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

PathLoc Lumbar Interbody Fusion Cage System is the device name listed in this FDA 510(k) record. The listed applicant is L&K BIOMED Co., Ltd.. It received FDA 510(k) clearance on 2025-07-08 under 510(k) number K251741. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PathLoc Lumbar Interbody Fusion Cage System?

PathLoc Lumbar Interbody Fusion Cage System is a medical device that received FDA 510(k) clearance on 2025-07-08. The listed applicant is L&K BIOMED Co., Ltd.. The 510(k) number is K251741.

When did PathLoc Lumbar Interbody Fusion Cage System receive FDA 510(k) clearance?

PathLoc Lumbar Interbody Fusion Cage System received FDA 510(k) clearance on 2025-07-08, under 510(k) number K251741.

Who is the listed applicant for PathLoc Lumbar Interbody Fusion Cage System?

The FDA 510(k) record lists L&K BIOMED Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PathLoc Lumbar Interbody Fusion Cage System?

The FDA product code for PathLoc Lumbar Interbody Fusion Cage System is MAX.

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Outros registros que listam L&K BIOMED Co., Ltd. como candidato(a)

K262489BluEX Cervical Expandable Cage System K260840BluEX Cervical Expandable Cage System K261112CastleLoc-P Anterior Cervical Plate System K261130AccelFix Spinal Fixation System K260448CastleLoc Pectus Bar System K251940PathLoc Lumbar Plate System

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Dispositivos Relacionados (Código: 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 SystemSeaSpine Orthopedics Corporation K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.

Fonte oficial

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