The following data is part of a premarket notification filed by Corin U.s.a. with the FDA for Trinity Polyaxial Screw, Mehdian Spinal Rod (6mm), Model 159.xxx Series Catalogue Numbers.
| Device ID | K010776 |
| 510k Number | K010776 |
| Device Name: | TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX SERIES CATALOGUE NUMBERS |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612 |
| Contact | Joel Batts |
| Correspondent | Joel Batts CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-14 |
| Decision Date | 2001-04-06 |