COFIED MODULAR SHOULDER SYSTEM

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

SMITH & NEPHEW RICHARDS, INC.

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

Pre-market Notification Details

• Device ID: K955767
• 510k Number: K955767
• Device Name: COFIED MODULAR SHOULDER SYSTEM
• Classification: Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
• Applicant: SMITH & NEPHEW RICHARDS, INC. 1450 E. BROOKS RD. Memphis, TN 38116
• Contact: Thomas L Craig
• Correspondent: Thomas L Craig; SMITH & NEPHEW RICHARDS, INC. 1450 E. BROOKS RD. Memphis, TN 38116
• Product Code: KWS
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent For Some Indications (SN)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-12-21
• Decision Date: 1996-04-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03596010189660	K955767	000
03596010189905	K955767	000
03596010189738	K955767	000
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