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, Rts Implant System, Neospan Compression Staple System.
| Device ID | K190385 |
| 510k Number | K190385 |
| Device Name: | CoLink Plating System, Fracture And Correction System, RTS Implant System, NeoSpan Compression Staple 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 |
| Subsequent Product Code | HWC |
| Subsequent Product Code | JDR |
| Subsequent Product Code | KWH |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-19 |
| Decision Date | 2019-08-08 |