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FDA 510(k)

AccelFix Lumbar Expandable Cage System

K-Number: K231680 · 2023-08-24

ApplicantL&K BIOMED Co., Ltd.
Decision Date2023-08-24
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AccelFix Lumbar Expandable 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 2023-08-24 under 510(k) number K231680. 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 AccelFix Lumbar Expandable Cage System?

AccelFix Lumbar Expandable Cage System is a medical device that received FDA 510(k) clearance on 2023-08-24. The listed applicant is L&K BIOMED Co., Ltd.. The 510(k) number is K231680.

When did AccelFix Lumbar Expandable Cage System receive FDA 510(k) clearance?

AccelFix Lumbar Expandable Cage System received FDA 510(k) clearance on 2023-08-24, under 510(k) number K231680.

Who is the listed applicant for AccelFix Lumbar Expandable 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 AccelFix Lumbar Expandable Cage System?

The FDA product code for AccelFix Lumbar Expandable Cage System is MAX.

Other records listing L&K BIOMED Co., Ltd. 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.

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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

View on FDA Database →

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

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