SMITH & NEPHEW MIS HIP STEM

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 Mis Hip Stem.

Pre-market Notification Details

• Device ID: K072417
• 510k Number: K072417
• Device Name: SMITH & NEPHEW MIS HIP STEM
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Contact: Rishi Sinha
• Correspondent: Rishi Sinha; SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Product Code: LPH
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-08-28
• Decision Date: 2008-01-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03596010619563	K072417	000
03596010619549	K072417	000
03596010619532	K072417	000