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 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 2025-06-02 under 510(k) 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. The listed applicant is Acuity Surgical Devices, LLC. The 510(k) number is K251335.

When did Tera Lumbar Interbody Fusion System (Various PNs) receive FDA 510(k) clearance?

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

Who is the listed applicant for Tera Lumbar Interbody Fusion 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 Tera Lumbar Interbody Fusion System (Various PNs)?

The FDA product code for Tera Lumbar Interbody Fusion System (Various PNs) is MAX.

Related Clinical Trials

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.

NCT048238583Spine Lumbar Fusion Real World Evidence StudyACTIVE_NOT_RECRUITING NCT05237908Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK CagesACTIVE_NOT_RECRUITING NCT05438719MOTUS Total Joint Replacement Investigational Device Exemption StudyACTIVE_NOT_RECRUITING NCT05583864Lumbar Fusion With Porous Versus Non-Porous CagesACTIVE_NOT_RECRUITING NCT06462729LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)RECRUITING NCT06904898CONDUIT vs. PEEK CagesACTIVE_NOT_RECRUITING

Other records listing Acuity Surgical Devices, LLC as applicant

K251735Stabilis SA Cervical Stand-Alone System (Various PNs)K243386Ventris Intervertebral Body Fusion Device K241413sagAlign Lumbar Cage System (Various PNs)K230639Align Cervical Interbody Fusion System K222561Align K221535Align Lumbar Interbody Fusion System

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Related Devices (Code: MAX)

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 Corporation K253151Fule 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.