VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW, ORTHEX CANNULATED BONE SCREW

Screw, Fixation, Bone

VILEX, INC.

The following data is part of a premarket notification filed by Vilex, Inc. with the FDA for Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw, Orthex Cannulated Bone Screw.

Pre-market Notification Details

• Device ID: K991151
• 510k Number: K991151
• Device Name: VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW, ORTHEX CANNULATED BONE SCREW
• Classification: Screw, Fixation, Bone
• Applicant: VILEX, INC. 1801 RT. 51, BUILDING 10 Jefferson Hills, PA 15025 -0724
• Contact: Abrahim Lavi
• Correspondent: Abrahim Lavi; VILEX, INC. 1801 RT. 51, BUILDING 10 Jefferson Hills, PA 15025 -0724
• Product Code: HWC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-04-06
• Decision Date: 1999-04-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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