WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / June 2026 / K253216

510(k) cleared

IntraOp Alignment System; CONTOUR3D Bending System

Alphatec Spine, Inc. · Jun 25, 2026 · K253216

FDA cleared the IntraOp Alignment System; CONTOUR3D Bending System from Alphatec Spine, Inc. on Jun 25, 2026 under K253216, a traditional 510(k). The device falls under product code SIN, Automated Intraoperative Spinal Rod Bending System, regulated at 21 CFR 888.3070 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 29, 2025. The decision came 269 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Alphatec Spine, Inc. has 4 other decisions in the tracker over the last 12 months: K261284 (Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation 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 K253216?

K253216 is the FDA 510(k) for IntraOp Alignment System; CONTOUR3D Bending System, submitted by Alphatec Spine, Inc.. FDA's decision date was Jun 25, 2026, under product code SIN (Automated Intraoperative Spinal Rod Bending System).

Who makes the IntraOp Alignment System; CONTOUR3D Bending System?

Alphatec Spine, Inc., based in Carlsbad, CA, is the applicant of record for K253216.

How long did the K253216 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Jun 25, 2026, 269 days later.

← All decisions in June 2026