The following data is part of a premarket notification filed by Avitus Orthopaedics, Inc with the FDA 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.
| Device ID | K170539 |
| 510k Number | K170539 |
| Device Name: | 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 |
| Classification | Instrument, Biopsy |
| Applicant | Avitus Orthopaedics, Inc 400 Farmington Ave Suite R2826, CB889 Farmington, CT 06032 |
| Contact | Maxim Budyansky |
| Correspondent | Maxim Budyansky Avitus Orthopaedics, Inc 400 Farmington Ave Suite R2826, CB889 Farmington, CT 06032 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-23 |
| Decision Date | 2017-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857373006050 | K170539 | 000 |
| 00857373006029 | K170539 | 000 |
| 00857373006074 | K170539 | 000 |