BePOD® Foot 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® Foot Screws.

Pre-market Notification Details

• Device ID: K163148
• 510k Number: K163148
• Device Name: BePOD® Foot Screws
• Classification: Screw, Fixation, Bone
• Applicant: Fournitures Hospitalieres Industrie ZI De Kernevez - 6 Rue Nobel Quimper, FR
• Contact: Patricia Donnard
• Correspondent: Patricia Donnard; Fournitures Hospitalieres Industrie ZI De Kernevez - 6 Rue Nobel Quimper, FR
• Product Code: HWC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-11-09
• Decision Date: 2017-09-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03661489681479	K163148	000
03661489581632	K163148	000
03661489581625	K163148	000
03661489581618	K163148	000
03661489581601	K163148	000
03661489581595	K163148	000
03661489581588	K163148	000
03661489574085	K163148	000
03661489564468	K163148	000
03661489562136	K163148	000
03661489581649	K163148	000
03661489642531	K163148	000
03661489672835	K163148	000
03661489665103	K163148	000
03661489657887	K163148	000
03661489656156	K163148	000
03661489656149	K163148	000
03661489656132	K163148	000
03661489645853	K163148	000
03661489642593	K163148	000
03661489642579	K163148	000
03661489549205	K163148	000