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 |
00810021865867 | K210060 | 000 |
00810021864563 | 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 |
00810021864716 | K210060 | 000 |