The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Oasys System.
| Device ID | K150539 |
| 510k Number | K150539 |
| Device Name: | OASYS System |
| Classification | Posterior Cervical Screw System |
| Applicant | Stryker Corporation 2 PEARL CT. Allendale, NJ 07401 -1677 |
| Contact | Garry T. Hayeck |
| Correspondent | Garry T. Hayeck STRYKER CORPORATION 2 PEARL CT. Allendale, NJ 07401 -1677 |
| Product Code | NKG |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-03 |
| Decision Date | 2015-05-12 |
| Summary: | summary |