DeviceClearance

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— 510(k) K170539

Substantially Equivalent

Avitus Orthopaedics, Inc.

FDA 510(k) clearance K170539 for 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, Substantially Equivalent on 2017-03-20. 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
Farmington, CT, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code KNW

view all

More clearances from Avitus Orthopaedics, Inc.

view all

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 K170539

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170539.

Data sourced from openFDA. This site is unofficial and independent of the FDA.