Stryker Universal Neuro III System AXS Screw
FDA 510(k) K171152 · Stryker
510(k) numberK171152
Submission
- Device name
- Stryker Universal Neuro III System AXS Screw
- Applicant
- Stryker
Portage, MI, US - Received
- April 20, 2017
- Decision date
- May 19, 2017
- 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 AXS Screw cleared by the FDA?
Stryker Universal Neuro III System AXS Screw (K171152) received a 510(k) decision of Substantially Equivalent on May 19, 2017, 29 days after the submission was received.
What is the product code of K171152?
The FDA product code is HBW – Fastener, Plate, Cranioplasty, a Class II (moderate risk) device regulated under 21 CFR 882.5360.