FDA 510(k)

Tera Lumbar Interbody Fusion System (Various PNs)

K-Number: K251335 · 2025-06-02

Decision Date2025-06-02

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Tera Lumbar Interbody Fusion System (Various PNs) is a medical device manufactured by Acuity Surgical Devices, LLC. It received FDA 510(k) clearance on 2025-06-02 under approval number K251335. 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 Tera Lumbar Interbody Fusion System (Various PNs)?

Tera Lumbar Interbody Fusion System (Various PNs) is a medical device that received FDA 510(k) clearance on 2025-06-02. It is manufactured by Acuity Surgical Devices, LLC. The 510(k) number is K251335.

When was Tera Lumbar Interbody Fusion System (Various PNs) approved by the FDA?

Tera Lumbar Interbody Fusion System (Various PNs) received FDA 510(k) clearance on 2025-06-02, under approval number K251335.

What company makes Tera Lumbar Interbody Fusion System (Various PNs)?

Tera Lumbar Interbody Fusion System (Various PNs) is manufactured by Acuity Surgical Devices, LLC.

What is the FDA product code for Tera Lumbar Interbody Fusion System (Various PNs)?

The FDA product code for Tera Lumbar Interbody Fusion 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 NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT07181590 BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_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

Related PubMed Literature

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 K221535Align Lumbar Interbody Fusion System K230639Align Cervical Interbody Fusion System K241413sagAlign Lumbar Cage System (Various PNs) K251735Stabilis SA Cervical Stand-Alone 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.