VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW, MODELS P222-XX, S25-XX, P227-XX, S30-XX, P235-XX, S35-XX, P240-XX, S40-XX, P24

Screw, Fixation, Bone

VILEX, INC.

The following data is part of a premarket notification filed by Vilex, Inc. with the FDA for Vilex/duval/orthex Cannulated Bone Screw, Models P222-xx, S25-xx, P227-xx, S30-xx, P235-xx, S35-xx, P240-xx, S40-xx, P24.

Pre-market Notification Details

• Device ID: K991197
• 510k Number: K991197
• Device Name: VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW, MODELS P222-XX, S25-XX, P227-XX, S30-XX, P235-XX, S35-XX, P240-XX, S40-XX, P24
• 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: 1999-04-07
• Decision Date: 1999-04-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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