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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 / July 2026 / K261284

510(k) cleared

Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System

Alphatec Spine, Inc. · Jul 14, 2026 · K261284

FDA cleared the Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System from Alphatec Spine, Inc. on Jul 14, 2026 under K261284, a traditional 510(k). The device falls under product code NKB, Thoracolumbosacral Pedicle Screw System, regulated at 21 CFR 888.3070 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Apr 17, 2026. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).

Alphatec Spine, Inc. has 4 other decisions in the tracker over the last 12 months: K253216 (IntraOp Alignment System; CONTOUR3D Bending System), K253615 (Invictus Bands System), K252597 (Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)), K252842 (SafeOp 3: Neural Informatix System).

Questions & Answers

What did FDA clear under K261284?

K261284 is the FDA 510(k) for Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System, submitted by Alphatec Spine, Inc.. FDA's decision date was Jul 14, 2026, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System?

Alphatec Spine, Inc., based in Carlsbad, CA, is the applicant of record for K261284.

How long did the K261284 review take?

FDA received the submission on Apr 17, 2026 and issued its decision on Jul 14, 2026, 88 days later.

← All decisions in July 2026