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SMART Osteotomy System

by Actis Medical Pty., Ltd. Australia(FDA 510(k) applicant) 510(k)

510(k) K260090 Product code HRS

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK260090 Date10 Apr 2026ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
HRS
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K260090 24 fields · synced 22 Oct 2026