The following data is part of a premarket notification filed by In2bones Usa, Llc with the FDA for Colink Vallux Plating System.
Device ID | K212487 |
510k Number | K212487 |
Device Name: | CoLink Vallux 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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-08-09 |
Decision Date | 2021-11-18 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00810021866291 | K212487 | 000 |
00810021866581 | K212487 | 000 |