SMV Scientific Bone Plate And Screw System

Plate, Fixation, Bone

SMV Scientific

The following data is part of a premarket notification filed by Smv Scientific with the FDA for Smv Scientific Bone Plate And Screw System.

Pre-market Notification Details

• Device ID: K152000
• 510k Number: K152000
• Device Name: SMV Scientific Bone Plate And Screw System
• Classification: Plate, Fixation, Bone
• Applicant: SMV Scientific 111 Sandra Muraida Way Unit 18A Austin, TX 78703
• Contact: Nephi Zufelt
• Correspondent: Kenneth C Maxwell Ii; Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-07-20
• Decision Date: 2015-11-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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