The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Stryker Spine Navigation System With Spinemap 3d Software Application, Ortholock, Ngenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap.
| Device ID | K172034 |
| 510k Number | K172034 |
| Device Name: | Stryker Spine Navigation System With SpineMap 3D Software Application, OrthoLock, NGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Stryker Corporation Boetzinger Strasse 41 Freiburg, DE D-79111 |
| Contact | Andrea Wallen-gerding |
| Correspondent | Andrea Wallen-gerding Stryker Corporation Boetzinger Strasse 41 Freiburg, DE D-79111 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-05 |
| Decision Date | 2017-10-18 |
| Summary: | summary |