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FDA 510(k)

sagAlign Lumbar Cage System (Various PNs)

K-Number: K241413 · 2024-07-17

ApplicantAcuity Surgical Devices, LLC
Decision Date2024-07-17
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

sagAlign Lumbar Cage System (Various PNs) is the device name listed in this FDA 510(k) record. The listed applicant is Acuity Surgical Devices, LLC. It received FDA 510(k) clearance on 2024-07-17 under 510(k) number K241413. 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 sagAlign Lumbar Cage System (Various PNs)?

sagAlign Lumbar Cage System (Various PNs) is a medical device that received FDA 510(k) clearance on 2024-07-17. The listed applicant is Acuity Surgical Devices, LLC. The 510(k) number is K241413.

When did sagAlign Lumbar Cage System (Various PNs) receive FDA 510(k) clearance?

sagAlign Lumbar Cage System (Various PNs) received FDA 510(k) clearance on 2024-07-17, under 510(k) number K241413.

Who is the listed applicant for sagAlign Lumbar Cage System (Various PNs)?

The FDA 510(k) record lists Acuity Surgical Devices, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for sagAlign Lumbar Cage System (Various PNs)?

The FDA product code for sagAlign Lumbar Cage System (Various PNs) is MAX.

Other records listing Acuity Surgical Devices, LLC 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.

K251735Stabilis SA Cervical Stand-Alone System (Various PNs)K251335Tera Lumbar Interbody Fusion System (Various PNs)K243386Ventris Intervertebral Body Fusion DeviceK230639Align Cervical Interbody Fusion SystemK222561AlignK221535Align Lumbar Interbody Fusion System

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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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