The following data is part of a premarket notification filed by Sulzer Spine-tech with the FDA for Modification To: Trinica Anterior Cervical Plate System.
| Device ID | K012305 |
| 510k Number | K012305 |
| Device Name: | MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SULZER SPINE-TECH 7375 BUSH LAKE RD. Minneapolis, MN 55439 -2027 |
| Contact | Janell A Colley |
| Correspondent | Janell A Colley SULZER SPINE-TECH 7375 BUSH LAKE RD. Minneapolis, MN 55439 -2027 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-23 |
| Decision Date | 2001-08-22 |
| Summary: | summary |