SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM

Shoulder Prosthesis, Reverse Configuration

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew, Inc., Promos Reverse Shoulder System.

Pre-market Notification Details

• Device ID: K081016
• 510k Number: K081016
• Device Name: SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM
• Classification: Shoulder Prosthesis, Reverse Configuration
• Applicant: SMITH & NEPHEW, INC. 1450 E BROOKS ROAD Memphis, TN 38116
• Contact: Jason Sells
• Correspondent: Jason Sells; SMITH & NEPHEW, INC. 1450 E BROOKS ROAD Memphis, TN 38116
• Product Code: PHX
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-04-09
• Decision Date: 2008-09-05
• Summary: summary

NIH GUDID Devices

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