The following data is part of a premarket notification filed by Stryker Spine with the FDA for Modification To: Oasys System.
| Device ID | K093670 |
| 510k Number | K093670 |
| Device Name: | MODIFICATION TO: OASYS SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | STRYKER SPINE 2 PEARL COURT Allendale, NJ 07401 |
| Contact | Pauline Shand |
| Correspondent | Pauline Shand STRYKER SPINE 2 PEARL COURT Allendale, NJ 07401 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-27 |
| Decision Date | 2010-03-18 |
| Summary: | summary |