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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 a medical device manufactured by Acuity Surgical Devices, LLC. It received FDA 510(k) clearance on 2024-07-17 under approval 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. It is manufactured by Acuity Surgical Devices, LLC. The 510(k) number is K241413.

When was sagAlign Lumbar Cage System (Various PNs) approved by the FDA?

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

What company makes sagAlign Lumbar Cage System (Various PNs)?

sagAlign Lumbar Cage System (Various PNs) is manufactured by Acuity Surgical Devices, LLC.

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.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT07181590 BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF RECRUITING NCT07034521 The Feasibility and Therapeutic Effect of Hybrid End-effector Robot-assisted Gait Training With an Active-assisted Module in Chronic Stroke Survivors RECRUITING NCT06655844 Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain RECRUITING NCT07277803 Device-Based vs Manual Sensory Training in Low Back Pain NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Acuity Surgical Devices, LLC

K201671A-Link Z K222561Align K221535Align Lumbar Interbody Fusion System K230639Align Cervical Interbody Fusion System K251735Stabilis SA Cervical Stand-Alone System (Various PNs) K251335Tera Lumbar Interbody Fusion System (Various PNs)

View all 8 devices →

Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, 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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