The following data is part of a premarket notification filed by In2bones Sas with the FDA for I.b.s. Osteosynthesis Screws.
| Device ID | K170594 |
| 510k Number | K170594 |
| Device Name: | I.B.S. Osteosynthesis Screws |
| 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 3100 N. Leisure World Blvd., Apt. 121 Silver Spring, MD 20906 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-28 |
| Decision Date | 2017-05-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760225715246 | K170594 | 000 |
| 03760225716045 | K170594 | 000 |
| 03760225716038 | K170594 | 000 |
| 03760225716021 | K170594 | 000 |
| 03760225716014 | K170594 | 000 |
| 03760225716007 | K170594 | 000 |
| 03760225715994 | K170594 | 000 |
| 03760225715932 | K170594 | 000 |
| 03760225715260 | K170594 | 000 |
| 03760225715253 | K170594 | 000 |
| 03760225715239 | K170594 | 000 |
| 03760225715222 | K170594 | 000 |
| 03760225715215 | K170594 | 000 |
| 03760225715208 | K170594 | 000 |
| 03760225716052 | K170594 | 000 |
| 03760225716069 | K170594 | 000 |
| 03760225716441 | K170594 | 000 |
| 03760225716328 | K170594 | 000 |
| 03760225716311 | K170594 | 000 |
| 03760225716304 | K170594 | 000 |
| 03760225716298 | K170594 | 000 |
| 03760225716281 | K170594 | 000 |
| 03760225716137 | K170594 | 000 |
| 03760225716120 | K170594 | 000 |
| 03760225716113 | K170594 | 000 |
| 03760225716106 | K170594 | 000 |
| 03760225716090 | K170594 | 000 |
| 03760225716083 | K170594 | 000 |
| 03760225716076 | K170594 | 000 |
| 03760225715192 | K170594 | 000 |