ARROW ANATOMICAL SHOULDER SYSTEM

Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

FOURNITURES HOSPITALIERES INDUSTRIE

The following data is part of a premarket notification filed by Fournitures Hospitalieres Industrie with the FDA for Arrow Anatomical Shoulder System.

Pre-market Notification Details

• Device ID: K093599
• 510k Number: K093599
• Device Name: ARROW ANATOMICAL SHOULDER SYSTEM
• Classification: Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
• Applicant: FOURNITURES HOSPITALIERES INDUSTRIE ZI DE KERNEVEZ-6 RUE NOBEL Quimper, FR 29000
• Contact: Patricia Donnard
• Correspondent: Patricia Donnard; FOURNITURES HOSPITALIERES INDUSTRIE ZI DE KERNEVEZ-6 RUE NOBEL Quimper, FR 29000
• Product Code: KWS
• Subsequent Product Code: HSD
• Subsequent Product Code: KWT
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-11-20
• Decision Date: 2010-11-24
• Summary: summary

NIH GUDID Devices

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