The following data is part of a premarket notification filed by In2bones Sas with the FDA for Os2(r)-vp Varisation Staple.
| Device ID | K153770 |
| 510k Number | K153770 |
| Device Name: | OS2(R)-VP Varisation Staple |
| Classification | Staple, 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 | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-30 |
| Decision Date | 2016-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760225715154 | K153770 | 000 |
| 03760225715147 | K153770 | 000 |