The following data is part of a premarket notification filed by In2bones Usa, Llc with the FDA for Colink View Plating System.
Device ID | K182402 |
510k Number | K182402 |
Device Name: | CoLink View Plating System |
Classification | Plate, Fixation, Bone |
Applicant | In2Bones USA, LLC 6060 Poplar Ave, Suite 380 Memphis, TN 38119 |
Contact | Christine Scifert |
Correspondent | Christine Scifert In2Bones USA, LLC 6060 Poplar Ave, Suite 380 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 | 2018-09-04 |
Decision Date | 2018-09-27 |