Stryker NAV3I Platform
FDA 510(k) K130874 · Stryker Corporate
510(k) numberK130874
Submission
- Device name
- Stryker NAV3I Platform
- Applicant
- Stryker Corporate
Freiburg, Baden-Wuerttemberg, DE - Received
- March 29, 2013
- Decision date
- September 27, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K253856 | Geniant Cranial (Navigated Neurosurgical Positioning Robot)HAW · Traditional | Koh Young Technology, Inc. | 09/10/2026SE |
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| K241327 | Navient Image Guide Navigation System (955-NC-NC), CranialHAW · Traditional | Claronav | 02/05/2025SE |
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| K131214 | Cranial Map NeuroHAW · Traditional | 10/18/2013SE |
Questions and answers
When was Stryker NAV3I Platform cleared by the FDA?
Stryker NAV3I Platform (K130874) received a 510(k) decision of Substantially Equivalent on September 27, 2013, 182 days after the submission was received.
What is the product code of K130874?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.