REFLECTION, TANDEM UNIPOLAR

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 Reflection, Tandem Unipolar.

Pre-market Notification Details

• Device ID: K071160
• 510k Number: K071160
• Device Name: REFLECTION, TANDEM UNIPOLAR
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Contact: Megan Bevill
• Correspondent: Megan Bevill; SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Product Code: LPH
• Subsequent Product Code: FZP
• Subsequent Product Code: JDI
• Subsequent Product Code: KWL
• Subsequent Product Code: KWY
• Subsequent Product Code: LWJ
• Subsequent Product Code: MEH
• Subsequent Product Code: NEU
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-04-26
• Decision Date: 2007-10-05

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00885556281994	K071160	000
00885556281949	K071160	000
00885556281895	K071160	000
00885556143117	K071160	000
00885556143100	K071160	000
00885556143094	K071160	000
00885556143087	K071160	000
00885556143070	K071160	000
00885556143063	K071160	000