The following data is part of a premarket notification filed by Sciences Et Bio Materiaux (sbm) with the FDA for Otis -c Plus.
| Device ID | K100604 |
| 510k Number | K100604 |
| Device Name: | OTIS -C PLUS |
| Classification | Plate, Fixation, Bone |
| Applicant | SCIENCES ET BIO MATERIAUX (SBM) ZI DU MONGE Lordes, FR F 65100 |
| Contact | Denis Clement |
| Correspondent | Denis Clement SCIENCES ET BIO MATERIAUX (SBM) ZI DU MONGE Lordes, FR F 65100 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-03 |
| Decision Date | 2010-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760154001281 | K100604 | 000 |
| 03760154001182 | K100604 | 000 |
| 03760154001199 | K100604 | 000 |
| 03760154001205 | K100604 | 000 |
| 03760154001212 | K100604 | 000 |
| 03760154001229 | K100604 | 000 |
| 03760154001236 | K100604 | 000 |
| 03760154001243 | K100604 | 000 |
| 03760154001250 | K100604 | 000 |
| 03760154001267 | K100604 | 000 |
| 03760154001274 | K100604 | 000 |
| 03760154001175 | K100604 | 000 |