The following data is part of a premarket notification filed by Avitus Orthopaedics, Inc. with the FDA for Avitus(r) Bone Harvester.
| Device ID | K210631 |
| 510k Number | K210631 |
| Device Name: | Avitus(r) Bone Harvester |
| Classification | Instrument, Biopsy |
| Applicant | Avitus Orthopaedics, Inc. 6 Amstrong Rd, Suite 107 Shelton, CT 06484 |
| Contact | Maxim Budyansky |
| Correspondent | William Mclain Keystone Regulatory Services, LLC 342 E. Main Street Leola, PA 17540 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-03 |
| Decision Date | 2021-03-31 |