Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade— 510(k) K151387
Substantially EquivalentStryker
FDA 510(k) clearance K151387 for Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade, Substantially Equivalent on 2015-06-24. Applicant: Stryker. Device class: 2.
Clearance details
- Applicant
- Stryker
- Product code
- Code HBW
- Device class
- Class 2
- Regulation
- 21 CFR 882.5360
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Portage, MI, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.