K172034 is an FDA 510(k) clearance for the 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. This device is classified as a Orthopedic Stereotaxic Instrument (Class II - Special Controls, product code OLO).
Submitted by Stryker Corporation (Freiburg, DE). The FDA issued a Cleared decision on October 18, 2017, 105 days after receiving the submission on July 5, 2017.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 882.4560. Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw..
| 510(k) Number | K172034 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2017 |
| Decision Date | October 18, 2017 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OLO — Orthopedic Stereotaxic Instrument |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |
| Definition | Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw. |