The following data is part of a premarket notification filed by In2bones Sas with the FDA for I.b.s. 2.0 Osteosynthesis Screw.
| Device ID | K160174 |
| 510k Number | K160174 |
| Device Name: | I.B.S. 2.0 Osteosynthesis Screw |
| Classification | Screw, Fixation, Bone |
| Applicant | In2Bones SAS 28 Chemin Du Petit Bois Ecully, FR 69130 |
| Contact | Morgane Grenier |
| Correspondent | Norman F Estrin Estrin Consulting Group LLC 9109 Copenhaver Drive Potomac, MD 20854 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-27 |
| Decision Date | 2016-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760225715321 | K160174 | 000 |
| 03760225714416 | K160174 | 000 |
| 03760225714409 | K160174 | 000 |
| 03760225714393 | K160174 | 000 |
| 03760225714386 | K160174 | 000 |
| 03760225714379 | K160174 | 000 |
| 03760225714362 | K160174 | 000 |
| 03760225714355 | K160174 | 000 |
| 03760225714348 | K160174 | 000 |
| 03760225714423 | K160174 | 000 |
| 03760225714430 | K160174 | 000 |
| 03760225715291 | K160174 | 000 |
| 03760225715284 | K160174 | 000 |
| 03760225715277 | K160174 | 000 |
| 03760225715369 | K160174 | 000 |
| 03760225715352 | K160174 | 000 |
| 03760225715345 | K160174 | 000 |
| 03760225715338 | K160174 | 000 |
| 03760225715314 | K160174 | 000 |
| 03760225715307 | K160174 | 000 |
| 03760225714331 | K160174 | 000 |