STRYKER UNIVERSAL NEURO 3 SYSTEM

Plate, Cranioplasty, Preformed, Alterable

Stryker

The following data is part of a premarket notification filed by Stryker with the FDA for Stryker Universal Neuro 3 System.

Pre-market Notification Details

• Device ID: K112557
• 510k Number: K112557
• Device Name: STRYKER UNIVERSAL NEURO 3 SYSTEM
• Classification: Plate, Cranioplasty, Preformed, Alterable
• Applicant: Stryker 750 TRADE CENTRE WAY STE 200 Portage, MI 49002
• Contact: Rob Yamashita
• Correspondent: Rob Yamashita; Stryker 750 TRADE CENTRE WAY STE 200 Portage, MI 49002
• Product Code: GWO
• Subsequent Product Code: GXR
• Subsequent Product Code: HBW
• CFR Regulation Number: 882.5320 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-09-02
• Decision Date: 2012-01-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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