Smith & Nephew Hip Systems

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

Smith & Nephew, Inc.

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

Pre-market Notification Details

• Device ID: K211176
• 510k Number: K211176
• Device Name: Smith & Nephew Hip Systems
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: Smith & Nephew, Inc. 1450 East Brooks Rd Memphis, TN 38116
• Contact: Crystal Higgenbottom-Shaffer
• Correspondent: Rose Beifuss; Smith & Nephew, Inc. 1450 East Brooks Rd Memphis, TN 38116
• Product Code: LPH
• Subsequent Product Code: JDI
• Subsequent Product Code: KWY
• Subsequent Product Code: KWZ
• Subsequent Product Code: LZO
• Subsequent Product Code: MBL
• Subsequent Product Code: MEH
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-04-20
• Decision Date: 2022-07-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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