Skip to content

Odys-SI Screw

by Medyssey Co., Ltd.

510(k) K262522

Odys-SI Screw is a Class II device made by Medyssey Co., Ltd., cleared under FDA 510(k) K262522 on 15 Oct 2026, active as of 1 Nov 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 1 Nov 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 1 Nov 2026.

Regulatory status

as of registry sync 1 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK262522 Date15 Oct 2026ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
OUR
FDA applicant
Medyssey Co, Ltd.
Device class
Class II
Regulation
21 CFR Part 888.3040
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Other devices from Medyssey Co., Ltd.