The following data is part of a premarket notification filed by Stryker Spine with the FDA for Zero Profile Anterior Cervical Plate (acp) System.
| Device ID | K063430 |
| 510k Number | K063430 |
| Device Name: | ZERO PROFILE ANTERIOR CERVICAL PLATE (ACP) SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | STRYKER SPINE 2 PEARL COURT Allendale, NJ 07401 |
| Contact | Simona Voic |
| Correspondent | Simona Voic STRYKER SPINE 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 | 2006-11-13 |
| Decision Date | 2007-03-22 |
| Summary: | summary |