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510(k) K230492

Avitus® Precision Autograft Delivery System by Avitus Orthopaedics, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2023
Date Received
February 23, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

Other clearances by Avitus Orthopaedics, Inc.

  • K231456 — Avitus® DragonWing Large Volume Autograft Delivery System (July 17, 2023)
  • K210631 — Avitus(r) Bone Harvester (March 31, 2021)
  • K170539 — Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avi (March 20, 2017)
  • K152474 — Avitus Bone Harvester (October 23, 2015)

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