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Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries

The Tracker / August 2026 / K262595

510(k) cleared

VariLift-C Cervical Interbody Fusion System

Wenzel Spine, Inc. · Aug 26, 2026 · K262595

FDA cleared the VariLift-C Cervical Interbody Fusion System from Wenzel Spine, Inc. on Aug 26, 2026 under K262595, a special 510(k). The device falls under product code ODP, Intervertebral Fusion Device With Bone Graft, Cervical, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jul 27, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Wenzel Spine, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262595?

K262595 is the FDA 510(k) for VariLift-C Cervical Interbody Fusion System, submitted by Wenzel Spine, Inc.. FDA's decision date was Aug 26, 2026, under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical).

Who makes the VariLift-C Cervical Interbody Fusion System?

Wenzel Spine, Inc., based in Austin, TX, is the applicant of record for K262595.

How long did the K262595 review take?

FDA received the submission on Jul 27, 2026 and issued its decision on Aug 26, 2026, 30 days later.

← All decisions in August 2026