The following data is part of a premarket notification filed by In2bones Sas with the FDA for Os2-v Varisation Staple.
| Device ID | K143323 |
| 510k Number | K143323 |
| Device Name: | OS2-V Varisation 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 | 2014-11-19 |
| Decision Date | 2015-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760225710838 | K143323 | 000 |
| 03760225710821 | K143323 | 000 |
| 03760225710814 | K143323 | 000 |
| 03760225710807 | K143323 | 000 |