The following data is part of a premarket notification filed by Stryker Spine with the FDA for Univise Spinous Process Fixation Plate (35mm, 40mm).
| Device ID | K132968 |
| 510k Number | K132968 |
| Device Name: | UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM) |
| Classification | Spinous Process Plate |
| Applicant | STRYKER SPINE 2 PEARL COURT Allendale, NJ 07401 |
| Contact | Kristen Meany, Ms, Cqa, Rac |
| Correspondent | Kristen Meany, Ms, Cqa, Rac STRYKER SPINE 2 PEARL COURT Allendale, NJ 07401 |
| Product Code | PEK |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-23 |
| Decision Date | 2013-11-18 |
| Summary: | summary |