The following data is part of a premarket notification filed by Science For Biomaterials with the FDA for Otis-c Plus.
| Device ID | K120818 |
| 510k Number | K120818 |
| Device Name: | OTIS-C PLUS |
| Classification | Plate, Fixation, Bone |
| Applicant | SCIENCE FOR BIOMATERIALS ZI DU MONGE Lourdes, FR F 65100 |
| Contact | Denis Clement |
| Correspondent | Denis Clement SCIENCE FOR BIOMATERIALS ZI DU MONGE Lourdes, FR F 65100 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-19 |
| Decision Date | 2012-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760154004794 | K120818 | 000 |
| 03760154005135 | K120818 | 000 |
| 03760154005142 | K120818 | 000 |
| 03760154007924 | K120818 | 000 |
| 03760154004145 | K120818 | 000 |
| 03760154004152 | K120818 | 000 |
| 03760154004169 | K120818 | 000 |
| 03760154004190 | K120818 | 000 |
| 03760154004459 | K120818 | 000 |
| 03760154004480 | K120818 | 000 |
| 03760154004497 | K120818 | 000 |
| 03760154004695 | K120818 | 000 |
| 03760154004701 | K120818 | 000 |
| 03760154004718 | K120818 | 000 |
| 03760154004732 | K120818 | 000 |
| 03760154004749 | K120818 | 000 |
| 03760154004756 | K120818 | 000 |
| 03760154004770 | K120818 | 000 |
| 03760154001397 | K120818 | 000 |