The following data is part of a premarket notification filed by In2bones Sas with the FDA for Os2-c Compression Staple.
| Device ID | K153395 |
| 510k Number | K153395 |
| Device Name: | OS2-C Compression Staple |
| Classification | Staple, Fixation, Bone |
| Applicant | IN2BONES SAS 28 CHEMIN DU PETIT BOIS Ecully, FR 63130 |
| Contact | Morgane Grenier |
| Correspondent | Norman F Estrin ESTRIN CONSULTING GROUP LLC 9109 COPENHAVER DRIVE Potomac, MD 20854 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-24 |
| Decision Date | 2016-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760225711163 | K153395 | 000 |
| 03760225711156 | K153395 | 000 |
| 03760225711149 | K153395 | 000 |