REFLECTION DUAL DIMENSION SHELL

Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous

SMITH & NEPHEW RICHARDS, INC.

The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Reflection Dual Dimension Shell.

Pre-market Notification Details

• Device ID: K960094
• 510k Number: K960094
• Device Name: REFLECTION DUAL DIMENSION SHELL
• Classification: Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous
• Applicant: SMITH & NEPHEW RICHARDS, INC. 1450 E. BROOKS RD. Memphis, TN 38116
• Contact: Tom Craig
• Correspondent: Tom Craig; SMITH & NEPHEW RICHARDS, INC. 1450 E. BROOKS RD. Memphis, TN 38116
• Product Code: MBL
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-01-11
• Decision Date: 1996-03-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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03596010197528	K960094	000
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