The following data is part of a premarket notification filed by Corelink, Llc with the FDA for Corelink Navigation Instruments.
| Device ID | K212825 |
| 510k Number | K212825 |
| Device Name: | CoreLink Navigation Instruments |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | CoreLink, LLC 2072 Fenton Logistics Park St. Louis, MO 63026 |
| Contact | Steven Mounts |
| Correspondent | Nathan Wright Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-03 |
| Decision Date | 2021-10-13 |