The following data is part of a premarket notification filed by Science For Biomaterials with the FDA for Otis-c-plus, Neotis Plate, Screw 06.5.
| Device ID | K140226 |
| 510k Number | K140226 |
| Device Name: | OTIS-C-PLUS, NEOTIS PLATE, SCREW 06.5 |
| Classification | Plate, Fixation, Bone |
| Applicant | SCIENCE FOR BIOMATERIALS ZI DU MONGE Lourdes, FR 65100 |
| Contact | Denis Clement |
| Correspondent | Denis Clement SCIENCE FOR BIOMATERIALS ZI DU MONGE Lourdes, FR 65100 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-29 |
| Decision Date | 2014-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760154001939 | K140226 | 000 |
| 03760154001922 | K140226 | 000 |