Avitus Bone Harvester— 510(k) K152474
Substantially EquivalentAvitus Orthopaedics, Inc.
FDA 510(k) clearance K152474 for Avitus Bone Harvester, Substantially Equivalent on 2015-10-23. 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
- Traditional
- Location
- Farmington, 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
- 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
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 →
Recalls naming K152474
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152474.
Data sourced from openFDA. This site is unofficial and independent of the FDA.