Cranial Map Neuro
FDA 510(k) K131214 · Stryker Corporate
510(k) numberK131214
Submission
- Device name
- Cranial Map Neuro
- Applicant
- Stryker Corporate
Freiburg, Baden-Wuerttemberg, DE - Received
- April 29, 2013
- Decision date
- October 18, 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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| K253663 | Zeta Navigation SystemHAW · Traditional | Zeta Surgical, Inc. | 05/01/2026SE |
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| K231897 | NeuroAlign softwareHAW · Traditional | Medivis, Inc. | 10/21/2025SE |
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| K250893 | Ball Joint Guide Array (66295)HAW · Traditional | Bayer Medical Care, Inc. | 09/04/2025SE |
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| K241327 | Navient Image Guide Navigation System (955-NC-NC), CranialHAW · Traditional | Claronav | 02/05/2025SE |
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| K153240 | Styrker OrthoMap Express Knee SystemOLO · Traditional | 07/07/2016SE |
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| K141941 | Spinemask Tracker, Spinemap 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE, Spinemap 3D…OLO · Traditional | 10/31/2014SE |
| K141551 | Profess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70 (Degrees)…PGW · Traditional | 09/08/2014SE |
| K130874 | Stryker NAV3I PlatformHAW · Traditional | 09/27/2013SE |
Questions and answers
When was Cranial Map Neuro cleared by the FDA?
Cranial Map Neuro (K131214) received a 510(k) decision of Substantially Equivalent on October 18, 2013, 172 days after the submission was received.
What is the product code of K131214?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.