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FDA 510(k)

Align Lumbar Interbody Fusion System

K-Number: K221535 · 2022-07-22

ApplicantAcuity Surgical Devices, LLC
Decision Date2022-07-22
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Align Lumbar Interbody Fusion System is a medical device manufactured by Acuity Surgical Devices, LLC. It received FDA 510(k) clearance on 2022-07-22 under approval number K221535. 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 Align Lumbar Interbody Fusion System?

Align Lumbar Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2022-07-22. It is manufactured by Acuity Surgical Devices, LLC. The 510(k) number is K221535.

When was Align Lumbar Interbody Fusion System approved by the FDA?

Align Lumbar Interbody Fusion System received FDA 510(k) clearance on 2022-07-22, under approval number K221535.

What company makes Align Lumbar Interbody Fusion System?

Align Lumbar Interbody Fusion System is manufactured by Acuity Surgical Devices, LLC.

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

The FDA product code for Align Lumbar Interbody Fusion System 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 NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING NCT07586098 AI-assisted Diagnosis, Triage and Assessment of Hearing Loss and Tinnitus NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026) PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) 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 K230639Align Cervical Interbody Fusion System K241413sagAlign Lumbar Cage System (Various PNs) 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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