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 |