Avitus® Precision Autograft Delivery System— 510(k) K230492
Substantially EquivalentAvitus Orthopaedics, Inc.
FDA 510(k) clearance K230492 for Avitus® Precision Autograft Delivery System, Substantially Equivalent on 2023-06-26. Applicant: Avitus Orthopaedics, Inc.. Device class: 2.
Clearance details
- Applicant
- Avitus Orthopaedics, Inc.
- Product code
- Code FMF
- Device class
- Class 2
- Regulation
- 21 CFR 880.5860
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shelton, CT, US
Recent devices under product code FMF
view allMore clearances from Avitus Orthopaedics, Inc.
view all- K231456 — Avitus® DragonWing Large Volume Autograft Delivery System
- K210631 — Avitus(r) Bone Harvester
- K170539 — Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm
- K152474 — Avitus Bone Harvester
Adverse events under product code FMF
product code FMF- Death
- 15
- Injury
- 2,263
- Malfunction
- 29,722
- Other
- 17
- Total
- 32,017
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.