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Spine Guidance 5.4 Software +9 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K253623
Identifiers
- 510(k) Number
- K253623 FDA 510(k)
- FDA Product Code
- OLO FDA 510(k)
- Models / Variants
- Spine Guidance 5.4 Software FDA 510(k)Spine Guidance 5.4 Upgrade FDA 510(k)Spine Guidance 5.4 Update FDA 510(k)Spine Guidance 5.4 Software Enable FDA 510(k)Spine Guidance 5.4 Sales Demo FDA 510(k)Q Drill Tracker FDA 510(k)NavLock Adapter FDA 510(k)Elite Q Attacments FDA 510(k)Elite Cutting Accessories FDA 510(k)Maestro Air Motor 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 5.4 Software +9 more models by Stryker Leibinger Gmbh & Co. Kg — Class II — FDA_510K — listed in FDA 510(k) — 10 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 | K253623 | 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) K253623 24 fields · synced Jun 18, 2026