The following data is part of a premarket notification filed by In2bones Sas with the FDA for Neoview Plating System.
| Device ID | K160995 |
| 510k Number | K160995 |
| Device Name: | NEOVIEW Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | In2Bones SAS 28 Chemin Du Petit Bois Ecully, FR 69130 |
| Contact | Morgane Grenier |
| Correspondent | Norman F Estrin Estrin Consulting Group LLC 9109 Copenhaver Drive Potomac, MD 20854 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-08 |
| Decision Date | 2016-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760225714027 | K160995 | 000 |
| 03760225713648 | K160995 | 000 |
| 03760225713631 | K160995 | 000 |
| 03760225713624 | K160995 | 000 |
| 03760225713617 | K160995 | 000 |
| 03760225713600 | K160995 | 000 |
| 03760225713594 | K160995 | 000 |
| 03760225713587 | K160995 | 000 |
| 03760225713570 | K160995 | 000 |
| 03760225713563 | K160995 | 000 |
| 03760225713556 | K160995 | 000 |
| 03760225713549 | K160995 | 000 |
| 03760225713655 | K160995 | 000 |
| 03760225713662 | K160995 | 000 |
| 03760225713679 | K160995 | 000 |
| 03760225713785 | K160995 | 000 |
| 03760225713778 | K160995 | 000 |
| 03760225713761 | K160995 | 000 |
| 03760225713754 | K160995 | 000 |
| 03760225713747 | K160995 | 000 |
| 03760225713730 | K160995 | 000 |
| 03760225713723 | K160995 | 000 |
| 03760225713716 | K160995 | 000 |
| 03760225713709 | K160995 | 000 |
| 03760225713693 | K160995 | 000 |
| 03760225713686 | K160995 | 000 |
| 03760225713532 | K160995 | 000 |