510(k) K240662 ยท OLO Orthopedic Stereotaxic Instrument
Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece
| Applicant | Stryker Leibinger GmbH & Co KG, Freiburg Im Breisgau, DE |
| Decision | Substantially Equivalent, Jun 6, 2024 |
| Received | Mar 8, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240662
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.