The following data is part of a premarket notification filed by Stryker Leibinger Gmbh & Co. Kg with the FDA for Spine Guidance Software, Stryker Q Guidance System.
| Device ID | K220593 |
| 510k Number | K220593 |
| Device Name: | Spine Guidance Software, Stryker Q Guidance System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Stryker Leibinger GmbH & Co. KG Bötzinger Straße 41 Freiburg, DE D-79111 |
| Contact | Andrea Wallen-Gerding |
| Correspondent | Andrea Wallen-Gerding Stryker Leibinger GmbH & Co. KG Bötzinger 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 | 2022-03-01 |
| Decision Date | 2022-05-27 |