BePOD® EZ Weil Screws

Screw, Fixation, Bone

Fournitures Hospitalieres Industrie

The following data is part of a premarket notification filed by Fournitures Hospitalieres Industrie with the FDA for Bepod® Ez Weil Screws.

Pre-market Notification Details

• Device ID: K163710
• 510k Number: K163710
• Device Name: BePOD® EZ Weil Screws
• Classification: Screw, Fixation, Bone
• Applicant: Fournitures Hospitalieres Industrie Zi De Kernevez - 6 Rue Nobel Quimper, FR 29000
• Contact: Patricia Donnard
• Correspondent: Patricia Donnard; Fournitures Hospitalieres Industrie 6 Rue Nobel, Z.I. De Kernévez Quimper, FR 29000
• Product Code: HWC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-12-30
• Decision Date: 2017-09-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03661489668180	K163710	000
03661489662539	K163710	000
03661489657702	K163710	000