The following data is part of a premarket notification filed by Corin U.s.a. with the FDA for Cervive Anterior Cervical Plating System, Model Number 157.xxx Series Catalogue Numbers.
| Device ID | K022798 |
| 510k Number | K022798 |
| Device Name: | CERVIVE ANTERIOR CERVICAL PLATING SYSTEM, MODEL NUMBER 157.XXX SERIES CATALOGUE NUMBERS |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612 |
| Contact | Joel K Batts |
| Correspondent | Joel K Batts CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-23 |
| Decision Date | 2002-11-19 |
| Summary: | summary |