The following data is part of a premarket notification filed by In2bones Usa, Llc with the FDA for Colink Cfx Plating System.
| Device ID | K200762 |
| 510k Number | K200762 |
| Device Name: | CoLink Cfx 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 | 2020-03-24 |
| Decision Date | 2020-04-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810021862248 | K200762 | 000 |
| 00810021862057 | K200762 | 000 |
| 00810021862040 | K200762 | 000 |
| 00810021862033 | K200762 | 000 |
| 00810021862026 | K200762 | 000 |
| 00810021862019 | K200762 | 000 |
| 00810021862002 | K200762 | 000 |
| 00810021861999 | K200762 | 000 |
| 00810021861982 | K200762 | 000 |
| 00810021861975 | K200762 | 000 |
| 00810021862064 | K200762 | 000 |
| 00810021862071 | K200762 | 000 |
| 00810021862224 | K200762 | 000 |
| 00810021862217 | K200762 | 000 |
| 00810021862200 | K200762 | 000 |
| 00810021862170 | K200762 | 000 |
| 00810021862125 | K200762 | 000 |
| 00810021862118 | K200762 | 000 |
| 00810021862101 | K200762 | 000 |
| 00810021862095 | K200762 | 000 |
| 00810021862088 | K200762 | 000 |
| 00810021862231 | K200762 | 000 |