SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM

Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

SMITH & NEPHEW, INC.

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

Pre-market Notification Details

• Device ID: K023743
• 510k Number: K023743
• Device Name: SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM
• Classification: Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
• Applicant: SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Contact: Janet Johnson Akil
• Correspondent: Janet Johnson Akil; SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Product Code: KWY
• CFR Regulation Number: 888.3390 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-11-07
• Decision Date: 2003-01-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00885556018699	K023743	000
03596010492432	K023743	000
03596010492449	K023743	000
03596010492456	K023743	000
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