Avitus(r) Bone Harvester— 510(k) K210631
Substantially EquivalentAvitus Orthopaedics, Inc.
FDA 510(k) clearance K210631 for Avitus(r) Bone Harvester, Substantially Equivalent on 2021-03-31. Applicant: Avitus Orthopaedics, Inc.. Device class: 2.
Clearance details
- Applicant
- Avitus Orthopaedics, Inc.
- Product code
- Code KNW
- Device class
- Class 2
- Regulation
- 21 CFR 876.1075
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Shelton, CT, US
Recent devices under product code KNW
view allMore clearances from Avitus Orthopaedics, Inc.
view all- K231456 — Avitus® DragonWing Large Volume Autograft Delivery System
- K230492 — Avitus® Precision Autograft Delivery System
- 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 KNW
product code KNW- Death
- 9
- Injury
- 965
- Malfunction
- 10,444
- Other
- 3
- Total
- 11,421
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.