The following data is part of a premarket notification filed by In2bones Usa, Llc with the FDA for Colink Plating System, Fracture And Correction System, Colink Mini Plating System, Colink View Plating System, Colink Afx Plating System.
| Device ID | K193543 |
| 510k Number | K193543 |
| Device Name: | CoLink Plating System, Fracture And Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-20 |
| Decision Date | 2020-01-17 |