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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / October 2025 / K253377

510(k) cleared

Expandable Titanium PLIF/TLIF System

Spectrum Spine, Inc. · Oct 24, 2025 · K253377

FDA cleared the Expandable Titanium PLIF/TLIF System from Spectrum Spine, Inc. on Oct 24, 2025 under K253377, a special 510(k). The device falls under product code MAX, Intervertebral Fusion Device With Bone Graft, Lumbar, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 30, 2025. The decision came 24 days later, inside the 90 FDA-day goal for a 510(k).

Spectrum Spine, Inc. has one other decision in the tracker over the last 12 months: K252240 (Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System).

Questions & Answers

What did FDA clear under K253377?

K253377 is the FDA 510(k) for Expandable Titanium PLIF/TLIF System, submitted by Spectrum Spine, Inc.. FDA's decision date was Oct 24, 2025, under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).

Who makes the Expandable Titanium PLIF/TLIF System?

Spectrum Spine, Inc., based in Jasper, GA, is the applicant of record for K253377.

How long did the K253377 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Oct 24, 2025, 24 days later.

← All decisions in October 2025

Sources