The following data is part of a premarket notification filed by Sbm Sciences For Bio Materials with the FDA for Neotis; Neotis 50.
| Device ID | K130953 |
| 510k Number | K130953 |
| Device Name: | NEOTIS; NEOTIS 50 |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | SBM SCIENCES FOR BIO MATERIALS ZI DU MONGE Lourdes, FR 65100 |
| Contact | Denis Clement |
| Correspondent | Denis Clement SBM SCIENCES FOR BIO MATERIALS ZI DU MONGE Lourdes, FR 65100 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-05 |
| Decision Date | 2013-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760154002318 | K130953 | 000 |
| 03760304680496 | K130953 | 000 |
| 03760304680489 | K130953 | 000 |
| 03760304680472 | K130953 | 000 |
| 03760304680465 | K130953 | 000 |
| 03760304680458 | K130953 | 000 |
| 03760304680441 | K130953 | 000 |
| 03760304680434 | K130953 | 000 |
| 03760304680427 | K130953 | 000 |
| 03760304680410 | K130953 | 000 |
| 03760154001946 | K130953 | 000 |
| 03760154001953 | K130953 | 000 |
| 03760154001977 | K130953 | 000 |
| 03760154002301 | K130953 | 000 |
| 03760154002288 | K130953 | 000 |
| 03760154002219 | K130953 | 000 |
| 03760154002158 | K130953 | 000 |
| 03760154002042 | K130953 | 000 |
| 03760154002028 | K130953 | 000 |
| 03760154001991 | K130953 | 000 |
| 03760154001960 | K130953 | 000 |
| 03760304680403 | K130953 | 000 |