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Spine Guidance Software (version 5.0) +8 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K240662
Identifiers
- 510(k) Number
- K240662 FDA 510(k)
- FDA Product Code
- OLO FDA 510(k)
- Models / Variants
- Spine Guidance Software (version 5.0) FDA 510(k)Xia 3/ Serrato Q Instruments FDA 510(k)Everest Q Instruments FDA 510(k)Mesa 2 Q Instruments FDA 510(k)Q Pedicle Preparation Instruments FDA 510(k)Q S2AI Drills FDA 510(k)Q Handles FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4560 FDA 510(k)
- Regulation Number
- 882.4560 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Spine Guidance Software (version 5.0) +8 more models by Stryker Leibinger Gmbh & Co. Kg — Class II — FDA_510K — listed in FDA 510(k) — 9 models
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240662 | Class II | Active |
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Manufacturer
- Manufacturer
- Stryker Leibinger Gmbh & Co. Kg
- FDA Applicant
- Stryker Leibinger GmbH & Co KG
Sources (1)
- FDA 510(k) K240662 24 fields · synced Jun 19, 2026