SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION

Pin, Fixation, Threaded

SMITH & NEPHEW, INC.

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

Pre-market Notification Details

• Device ID: K120871
• 510k Number: K120871
• Device Name: SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION
• Classification: Pin, Fixation, Threaded
• Applicant: SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Contact: Gino Rouss
• Correspondent: Gino Rouss; SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Product Code: JDW
• Subsequent Product Code: KTT
• Subsequent Product Code: LXT
• Subsequent Product Code: OSN
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-03-22
• Decision Date: 2012-06-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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