The following data is part of a premarket notification filed by In2bones Sas with the FDA for Pit’stop® Implant.
| Device ID | K170688 |
| 510k Number | K170688 |
| Device Name: | PIT’Stop® Implant |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-07 |
| Decision Date | 2017-11-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760225713396 | K170688 | 000 |
| 03760225713389 | K170688 | 000 |
| 03760225713372 | K170688 | 000 |
| 03760225713365 | K170688 | 000 |
| 03760225713358 | K170688 | 000 |
| 03760225713341 | K170688 | 000 |
| 03760225713334 | K170688 | 000 |