Cleared Traditional

Tera Lumbar Interbody Fusion System (Various PNs)

K251335 · Acuity Surgical Devices, LLC · Orthopedic

Jun 2025

Decision

33d

Days

Class 2

Risk

About This 510(k) Submission

K251335 is an FDA 510(k) clearance for the Tera Lumbar Interbody Fusion System (Various PNs), a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Acuity Surgical Devices, LLC (Irving, US). The FDA issued a Cleared decision on June 2, 2025, 33 days after receiving the submission on April 30, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K251335 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 30, 2025
Decision Date	June 02, 2025
Days to Decision	33 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.