SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1

Orthopedic Stereotaxic Instrument

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1.

Pre-market Notification Details

• Device ID: K110240
• 510k Number: K110240
• Device Name: SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1
• Classification: Orthopedic Stereotaxic Instrument
• Applicant: SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Contact: Shereen Myers
• Correspondent: Shereen Myers; SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Product Code: OLO
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-01-27
• Decision Date: 2011-04-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00885556195284	K110240	000
03596010656681	K110240	000
03596010656643	K110240	000
03596010656636	K110240	000