The following data is part of a premarket notification filed by Stryker Spine with the FDA for Modification To: Stryker Spine Oasys System.
| Device ID | K052317 |
| 510k Number | K052317 |
| Device Name: | MODIFICATION TO: STRYKER SPINE OASYS SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | STRYKER SPINE 2 PEARL COURT Allendale, NJ 07401 |
| Contact | Simona Voic |
| Correspondent | Simona Voic STRYKER SPINE 2 PEARL COURT Allendale, NJ 07401 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-25 |
| Decision Date | 2005-09-21 |
| Summary: | summary |