K170539 is an FDA 510(k) clearance for the 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. This device is classified as a Instrument, Biopsy (Class II - Special Controls, product code KNW).
Submitted by Avitus Orthopaedics, Inc. (Farmington, US). The FDA issued a Cleared decision on March 20, 2017, 25 days after receiving the submission on February 23, 2017.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K170539 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 2017 |
| Decision Date | March 20, 2017 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNW - Instrument, Biopsy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |