The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Stryker Spine Reflex Translational Anterior Cervical Plating System.
| Device ID | K083020 |
| 510k Number | K083020 |
| Device Name: | STRYKER SPINE REFLEX TRANSLATIONAL ANTERIOR CERVICAL PLATING SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | STRYKER CORP. 2 PEARL COURT Allendale, NJ 07401 |
| Contact | Kimberly Lane |
| Correspondent | Kimberly Lane STRYKER CORP. 2 PEARL COURT Allendale, NJ 07401 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-09 |
| Decision Date | 2009-03-26 |
| Summary: | summary |