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FDA posts two worked PCCP examples for machine learning devices Haemonetics wins FDA approval for a patch that seals 26F arteriotomies FDA adds Olympus enteroscopes and capsule systems to Import Alert 89-04 Nova Biomedical pulls Gen 2.0 StatStrip glucose meters over stale barcode scans AdvaMed plans industry cybersecurity standards written like a code of ethics 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 Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Paradromics hands Siemens Healthineers the imaging workup for its brain implant FDA posts two worked PCCP examples for machine learning devices Haemonetics wins FDA approval for a patch that seals 26F arteriotomies FDA adds Olympus enteroscopes and capsule systems to Import Alert 89-04 Nova Biomedical pulls Gen 2.0 StatStrip glucose meters over stale barcode scans AdvaMed plans industry cybersecurity standards written like a code of ethics 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 Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Paradromics hands Siemens Healthineers the imaging workup for its brain implant

The Tracker / October 2026 / K262522

510(k) cleared

Odys-SI Screw

Medyssey Co, Ltd. · Oct 15, 2026 · K262522

FDA cleared the Odys-SI Screw from Medyssey Co, Ltd. on Oct 15, 2026 under K262522, a traditional 510(k). The device falls under product code OUR, Sacroiliac Joint Fixation, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jul 22, 2026. The decision came 85 days later, inside the 90 FDA-day goal for a 510(k).

Medyssey Co, Ltd. has 2 other decisions in the tracker over the last 12 months: K262726 (NeckTune SA Cervical Cage), K260036 (NeckTune 3D SA Cervical Cage).

Questions & Answers

What did FDA clear under K262522?

K262522 is the FDA 510(k) for Odys-SI Screw, submitted by Medyssey Co, Ltd.. FDA's decision date was Oct 15, 2026, under product code OUR (Sacroiliac Joint Fixation).

Who makes the Odys-SI Screw?

Medyssey Co, Ltd., based in Jecheon-Si, is the applicant of record for K262522.

How long did the K262522 review take?

FDA received the submission on Jul 22, 2026 and issued its decision on Oct 15, 2026, 85 days later.

← All decisions in October 2026

Sources