The following data is part of a premarket notification filed by In2bones Usa, Llc with the FDA for Colink Mfx Implant System.
| Device ID | K210060 |
| 510k Number | K210060 |
| Device Name: | CoLink Mfx Implant System |
| Classification | Plate, Fixation, Bone |
| 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-11 |
| Decision Date | 2021-03-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810021864686 | K210060 | 000 |
| 00810021864570 | K210060 | 000 |
| 00810021864587 | K210060 | 000 |
| 00810021864594 | K210060 | 000 |
| 00810021864600 | K210060 | 000 |
| 00810021864617 | K210060 | 000 |
| 00810021864624 | K210060 | 000 |
| 00810021864631 | K210060 | 000 |
| 00810021864648 | K210060 | 000 |
| 00810021864655 | K210060 | 000 |
| 00810021864662 | K210060 | 000 |
| 00810021864679 | K210060 | 000 |
| 00810021864563 | K210060 | 000 |