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 |