The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Stryker Spine Oasys Bone Screw.
| Device ID | K031657 |
| 510k Number | K031657 |
| Device Name: | STRYKER SPINE OASYS BONE SCREW |
| Classification | System, Facet Screw Spinal Device |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Karen Ariemma |
| Correspondent | Karen Ariemma HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | MRW |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-28 |
| Decision Date | 2003-08-22 |
| Summary: | summary |