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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 / K262506

510(k) cleared

Remex Spine Surgery Navigation - Universal Instruments

Remex Medical Corp. · Aug 20, 2026 · K262506

FDA cleared the Remex Spine Surgery Navigation - Universal Instruments from Remex Medical Corp. on Aug 20, 2026 under K262506, a special 510(k). The device falls under product code OLO, Orthopedic Stereotaxic Instrument, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jul 21, 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 Remex Medical Corp. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262506?

K262506 is the FDA 510(k) for Remex Spine Surgery Navigation - Universal Instruments, submitted by Remex Medical Corp.. FDA's decision date was Aug 20, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the Remex Spine Surgery Navigation - Universal Instruments?

Remex Medical Corp., based in Taichung, is the applicant of record for K262506.

How long did the K262506 review take?

FDA received the submission on Jul 21, 2026 and issued its decision on Aug 20, 2026, 30 days later.

← All decisions in August 2026