Bone Screw Line Addition

Screw, Fixation, Bone

Vilex In Tennessee, Inc

The following data is part of a premarket notification filed by Vilex In Tennessee, Inc with the FDA for Bone Screw Line Addition.

Pre-market Notification Details

• Device ID: K191289
• 510k Number: K191289
• Device Name: Bone Screw Line Addition
• Classification: Screw, Fixation, Bone
• Applicant: Vilex In Tennessee, Inc 111 Moffitt Street Mcminnville, TN 37110
• Contact: Victor Lavi
• Correspondent: Victor Lavi; Vilex In Tennessee, Inc 111 Moffitt Street Mcminnville, TN 37110
• Product Code: HWC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-05-13
• Decision Date: 2019-07-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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