VILEX CANNULATED BONE SCREW, DUVAL 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.

Pre-market Notification Details

• Device ID: K973309
• 510k Number: K973309
• Device Name: VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW
• Classification: Screw, Fixation, Bone
• Applicant: VILEX, INC. 811 RT. 51, INDUSTRIAL COMPLEX BLDG. 10 Large, PA 15025
• Contact: Abraham Lavi
• Correspondent: Abraham Lavi; VILEX, INC. 811 RT. 51, INDUSTRIAL COMPLEX BLDG. 10 Large, PA 15025
• Product Code: HWC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent For Some Indications (SN)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-09-03
• Decision Date: 1998-01-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841731103536	K973309	000
00841731103314	K973309	000
00841731103307	K973309	000
00841731103291	K973309	000
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00841731103451	K973309	000
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00841731103833	K973309	000
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