The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Oasys System.
| Device ID | K142741 |
| 510k Number | K142741 |
| Device Name: | OASYS System |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | STRYKER CORPORATION 2 PEARL COURT Allendale, NJ 07401 |
| Contact | Garry T Hayeck |
| Correspondent | Garry T Hayeck STRYKER CORPORATION 2 PEARL COURT Allendale, NJ 07401 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-24 |
| Decision Date | 2015-01-15 |
| Summary: | summary |