Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade
FDA 510(k) K151387 · Stryker
510(k) numberK151387
Submission
- Device name
- Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade
- Applicant
- Stryker
Portage, MI, US - Received
- May 26, 2015
- Decision date
- June 24, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade cleared by the FDA?
Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade (K151387) received a 510(k) decision of Substantially Equivalent on June 24, 2015, 29 days after the submission was received.
What is the product code of K151387?
The FDA product code is HBW – Fastener, Plate, Cranioplasty, a Class II (moderate risk) device regulated under 21 CFR 882.5360.