The following data is part of a premarket notification filed by In2bones Usa, Llc with the FDA for Colink Pcr Plating System.
| Device ID | K213698 |
| 510k Number | K213698 |
| Device Name: | CoLink PCR 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 | 2021-11-23 |
| Decision Date | 2022-05-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810021864556 | K213698 | 000 |
| 00810021864549 | K213698 | 000 |
| 00810021864532 | K213698 | 000 |
| 00810021864525 | K213698 | 000 |
| 00810021864518 | K213698 | 000 |
| 00810021864501 | K213698 | 000 |
| 00810021864495 | K213698 | 000 |
| 00810021864488 | K213698 | 000 |
| 00810021864471 | K213698 | 000 |