Home / 510(k) Clearances / K261145

510(k) K261145

Avanti Distal Elbow ORIF System by Avanti Orthopaedics, LLC — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2026
Date Received
April 7, 2026
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Avanti Orthopaedics, LLC

  • K222967 — Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm (November 23, 2022)
  • K211592 — Avanti Orthopaedics Ulnar Shortening System (July 16, 2021)
  • K191118 — Avanti Distal Radius and Forearm System (December 13, 2019)

Other clearances for product code HRS

  • K260958 — I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with An (June 16, 2026)
  • K261207 — Exalta Proximal Tibia Plating System (June 12, 2026)
  • K260761 — APTUS Clavicle System 2.8 (June 5, 2026)
  • K261002 — Pectus Blu System (June 2, 2026)
  • K261038 — Xpert PFP (May 29, 2026)
  • K260323 — OrthoPediatrics® Locking Cannulated Blade Plate System (April 30, 2026)
  • K260228 — POYA 3.5mm Medial Proximal Tibia System (April 24, 2026)
  • K260411 — PC Fix System (April 24, 2026)
  • K260054 — I.T.S. PRS Phoenix II (April 24, 2026)
  • K260090 — SMART Osteotomy System (April 10, 2026)