The following data is part of a premarket notification filed by Corelink, Llc with the FDA for The Entasis Dual-lead Sacroiliac Implant.
| Device ID | K152237 |
| 510k Number | K152237 |
| Device Name: | The Entasis Dual-Lead Sacroiliac Implant |
| Classification | Sacroiliac Joint Fixation |
| Applicant | CoreLink, LLC 7606 Forsyth Blvd St.louis, MO 63105 |
| Contact | Dan Hoehn |
| Correspondent | Kenneth C Maxwell Ii Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | OUR |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-10 |
| Decision Date | 2016-02-04 |
| Summary: | summary |