PRECICE Plating System

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

NuVasive Specialized Orthopedics, Inc.

The following data is part of a premarket notification filed by Nuvasive Specialized Orthopedics, Inc. with the FDA for Precice Plating System.

Pre-market Notification Details

• Device ID: K192181
• 510k Number: K192181
• Device Name: PRECICE Plating System
• Classification: Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
• Applicant: NuVasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo, CA 92656
• Contact: Madison Heffron
• Correspondent: Madison Heffron; NuVasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo, CA 92656
• Product Code: KTT
• Subsequent Product Code: HRS
• Subsequent Product Code: HWC
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-08-12
• Decision Date: 2019-11-07

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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