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FDA 510(k)

SWINGO-3D Lumbar Cage System

K-Number: K254017 · 2026-02-26

ApplicantImplanet
Decision Date2026-02-26
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SWINGO-3D Lumbar Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Implanet. It received FDA 510(k) clearance on 2026-02-26 under 510(k) number K254017. 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 SWINGO-3D Lumbar Cage System?

SWINGO-3D Lumbar Cage System is a medical device that received FDA 510(k) clearance on 2026-02-26. The listed applicant is Implanet. The 510(k) number is K254017.

When did SWINGO-3D Lumbar Cage System receive FDA 510(k) clearance?

SWINGO-3D Lumbar Cage System received FDA 510(k) clearance on 2026-02-26, under 510(k) number K254017.

Who is the listed applicant for SWINGO-3D Lumbar Cage System?

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

What is the FDA product code for SWINGO-3D Lumbar Cage System?

The FDA product code for SWINGO-3D Lumbar Cage System is MAX.

Other records listing Implanet 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.

K252437JAZZ Spinal SystemK240392JAZZ Spinal System

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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