The following data is part of a premarket notification filed by Avitus Orthopaedics Inc. with the FDA for Avitus Bone Harvester.
| Device ID | K152474 |
| 510k Number | K152474 |
| Device Name: | Avitus Bone Harvester |
| Classification | Instrument, Biopsy |
| Applicant | Avitus Orthopaedics Inc. 400 Farmington Ave Suite R1717 Farmington, CT 06032 |
| Contact | Maxim Budyansky |
| Correspondent | Maxim Budyansky Avitus Orthopaedics Inc. 400 Farmington Ave Suite R1717 Farmington, CT 06032 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-31 |
| Decision Date | 2015-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857373006005 | K152474 | 000 |