The following data is part of a premarket notification filed by Neo Medical Sa with the FDA for Bonos Inject Bone Cement; Neo Pedicle Screw System.
| Device ID | K212489 |
| 510k Number | K212489 |
| Device Name: | BonOs Inject Bone Cement; NEO Pedicle Screw System |
| Classification | Bone Cement, Posterior Screw Augmentation |
| Applicant | Neo Medical SA Route De Lausanne 157 A Villette (lavaux), CH 1096 |
| Contact | Jonas Larsson |
| Correspondent | Sandra Soniec meditec Consulting GmbH Obermoosstrasse 23 Boll, CH 3067 |
| Product Code | PML |
| Subsequent Product Code | NDN |
| Subsequent Product Code | NKB |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-09 |
| Decision Date | 2021-10-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640177820846 | K212489 | 000 |
| 07640177820525 | K212489 | 000 |
| 07640177820532 | K212489 | 000 |
| 07640177820549 | K212489 | 000 |
| 07640177820556 | K212489 | 000 |
| 07640177820563 | K212489 | 000 |
| 07640177820686 | K212489 | 000 |
| 07640177820693 | K212489 | 000 |
| 07640177820709 | K212489 | 000 |
| 07640177820716 | K212489 | 000 |
| 07640177820723 | K212489 | 000 |
| 07640177820730 | K212489 | 000 |
| 07640177820747 | K212489 | 000 |
| 07640177820754 | K212489 | 000 |
| 07640177820761 | K212489 | 000 |
| 07640177820518 | K212489 | 000 |