The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Oasys(r) System.
| Device ID | K151755 |
| 510k Number | K151755 |
| Device Name: | OASYS(r) System |
| Classification | Posterior Cervical Screw System |
| 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 | NKG |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-29 |
| Decision Date | 2015-07-09 |
| Summary: | summary |