The following data is part of a premarket notification filed by Bien-air Surgery Sa with the FDA for Osseoduo Shaver And Drill System.
| Device ID | K173066 |
| 510k Number | K173066 |
| Device Name: | OSSEODUO Shaver And Drill System |
| Classification | Motor, Drill, Electric |
| Applicant | Bien-Air Surgery SA Rue De I'Ouest 2b Le Noirmont, CH 2340 |
| Contact | Adil Slimani |
| Correspondent | Belia Juarez Ken Block Consulting 1201 Richardson Drive, Suite 160 Richardson, TX 75080 |
| Product Code | HBC |
| CFR Regulation Number | 882.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2018-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J00711004730011 | K173066 | 000 |
| J00716007660 | K173066 | 000 |
| J00716007650 | K173066 | 000 |
| J00711004610011 | K173066 | 000 |
| J00711004600011 | K173066 | 000 |
| J00711004590011 | K173066 | 000 |
| J00717005000011 | K173066 | 000 |
| J00716009780 | K173066 | 000 |
| J00716009770 | K173066 | 000 |
| 27630055503712 | K173066 | 000 |
| 17630055503708 | K173066 | 000 |
| 27630055503521 | K173066 | 000 |
| 27630055503514 | K173066 | 000 |
| 17630055503500 | K173066 | 000 |
| 27630055503491 | K173066 | 000 |
| 27630055507482 | K173066 | 000 |
| 27630055507475 | K173066 | 000 |
| 27630055507468 | K173066 | 000 |
| J00716007680 | K173066 | 000 |
| J00716007690 | K173066 | 000 |
| J00711004720011 | K173066 | 000 |
| J00711003430011 | K173066 | 000 |
| J00711003420011 | K173066 | 000 |
| J00711003410011 | K173066 | 000 |
| J00711003400011 | K173066 | 000 |
| J00711003390011 | K173066 | 000 |
| J00711003380011 | K173066 | 000 |
| J00711003370011 | K173066 | 000 |
| J00711003360011 | K173066 | 000 |
| J00711003080011 | K173066 | 000 |
| J00716009130 | K173066 | 000 |
| J00716009120 | K173066 | 000 |
| J00716008870 | K173066 | 000 |
| J00716008800 | K173066 | 000 |
| J00716008790 | K173066 | 000 |
| J00716008320 | K173066 | 000 |
| J00716008300 | K173066 | 000 |
| 17630055507799 | K173066 | 000 |