The following data is part of a premarket notification filed by In2bones Usa, Llc with the FDA for Colink View Plating System.
| Device ID | K172300 |
| 510k Number | K172300 |
| Device Name: | CoLink View Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | In2Bones USA, LLC 6060 Poplar Ave, Suite 380 Memphis, TN 38119 |
| Contact | Rebecca Wahl |
| Correspondent | Christine Scifert MRC-X, LLC 6060 Poplar Ave Suite 380 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 | 2017-07-31 |
| Decision Date | 2017-11-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817906027907 | K172300 | 000 |
| 00817906020380 | K172300 | 000 |
| 00817906020373 | K172300 | 000 |
| 00817906020366 | K172300 | 000 |
| 00817906020359 | K172300 | 000 |
| 00817906020342 | K172300 | 000 |
| 00817906020335 | K172300 | 000 |
| 00817906020304 | K172300 | 000 |
| 00817906020298 | K172300 | 000 |
| 00817906020281 | K172300 | 000 |
| 00817906020397 | K172300 | 000 |
| 00817906021417 | K172300 | 000 |
| 00817906021424 | K172300 | 000 |
| 00817906027891 | K172300 | 000 |
| 00817906024197 | K172300 | 000 |
| 00817906024180 | K172300 | 000 |
| 00817906024173 | K172300 | 000 |
| 00817906024166 | K172300 | 000 |
| 00817906021462 | K172300 | 000 |
| 00817906021455 | K172300 | 000 |
| 00817906021448 | K172300 | 000 |
| 00817906021431 | K172300 | 000 |
| 00817906020274 | K172300 | 000 |