The following data is part of a premarket notification filed by Centerpulse Spine-tech, Inc. with the FDA for Trinica Select Anterior Cervical Plate System.
| Device ID | K022344 |
| 510k Number | K022344 |
| Device Name: | TRINICA SELECT ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | CENTERPULSE SPINE-TECH, INC. 7375 BUSH LAKE RD. Minneapolis, MN 55439 -3037 |
| Contact | Tim Miller |
| Correspondent | Tim Miller CENTERPULSE SPINE-TECH, INC. 7375 BUSH LAKE RD. Minneapolis, MN 55439 -3037 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-19 |
| Decision Date | 2002-09-24 |
| Summary: | summary |