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GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter

The Tracker / October 2026 / K262646

510(k) cleared

Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody System

Alphatec Spine, Inc. · Oct 21, 2026 · K262646

FDA cleared the Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody System from Alphatec Spine, Inc. on Oct 21, 2026 under K262646, a traditional 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 Jul 30, 2026. The decision came 83 days later, inside the 90 FDA-day goal for a 510(k).

Alphatec Spine, Inc. has 5 other decisions in the tracker over the last 12 months: K261284 (Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System), K253216 (IntraOp Alignment System; CONTOUR3D Bending System), K253615 (Invictus Bands System), K252597 (Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)).

Questions & Answers

What did FDA clear under K262646?

K262646 is the FDA 510(k) for Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody System, submitted by Alphatec Spine, Inc.. FDA's decision date was Oct 21, 2026, under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).

Who makes the Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody System?

Alphatec Spine, Inc., based in Carlsbad, CA, is the applicant of record for K262646.

How long did the K262646 review take?

FDA received the submission on Jul 30, 2026 and issued its decision on Oct 21, 2026, 83 days later.

← All decisions in October 2026