WHERE ARE YOU?

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

THE TAPE

Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / July 2026 / K261129

510(k) cleared

OrthoFit

Spident Co., Ltd. · Jul 2, 2026 · K261129

FDA cleared the OrthoFit from Spident Co., Ltd. on Jul 2, 2026 under K261129, a traditional 510(k). The device falls under product code DYH, Adhesive, Bracket And Tooth Conditioner, Resin, regulated at 21 CFR 872.3750 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Apr 6, 2026. The decision came 87 days later, inside the 90 FDA-day goal for a 510(k).

Spident Co., Ltd. has 3 other decisions in the tracker over the last 12 months: K262983 (EsTemp Implant), K262982 (Core·it Dual), K262050 (Vioseal X).

Questions & Answers

What did FDA clear under K261129?

K261129 is the FDA 510(k) for OrthoFit, submitted by Spident Co., Ltd.. FDA's decision date was Jul 2, 2026, under product code DYH (Adhesive, Bracket And Tooth Conditioner, Resin).

Who makes the OrthoFit?

Spident Co., Ltd., based in Incheon, is the applicant of record for K261129.

How long did the K261129 review take?

FDA received the submission on Apr 6, 2026 and issued its decision on Jul 2, 2026, 87 days later.

← All decisions in July 2026

Sources