The following data is part of a premarket notification filed by Corelink Llc with the FDA for Corelink Navigation Instruments.
| Device ID | K182731 |
| 510k Number | K182731 |
| Device Name: | Corelink Navigation Instruments |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Corelink LLC 7911 Forsyth Blvd, Suite #200 St. Louis, MO 63105 |
| Contact | Steven D. Mounts |
| Correspondent | Meredith May Corelink LLC 4628 Northpark Dr 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 | 2018-09-28 |
| Decision Date | 2019-12-13 |