The following data is part of a premarket notification filed by In2bones Usa, Llc with the FDA for Colink Sfx Implant System.
| Device ID | K203698 |
| 510k Number | K203698 |
| Device Name: | CoLink Sfx Implant System |
| Classification | Pin, Fixation, Smooth |
| Applicant | In2Bones USA, LLC 6000 Poplar Ave, Suite 115 Memphis, TN 38119 |
| Contact | Christine Scifert |
| Correspondent | Christine Scifert In2Bones USA, LLC 6000 Poplar Ave, Suite 115 Memphis, TN 38119 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-18 |
| Decision Date | 2021-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810021866284 | K203698 | 000 |
| 00810021864174 | K203698 | 000 |
| 00810021864181 | K203698 | 000 |
| 00810021864198 | K203698 | 000 |
| 00810021864204 | K203698 | 000 |
| 00810021864211 | K203698 | 000 |
| 00810021864228 | K203698 | 000 |
| 00810021864235 | K203698 | 000 |
| 00810021866260 | K203698 | 000 |
| 00810021866277 | K203698 | 000 |
| 00810021864167 | K203698 | 000 |