Smith And Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith And Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318, Smith And Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor, Smith And Nephew Suture Anchors - Ost

Fastener, Fixation, Biodegradable, Soft Tissue

Smith & Nephew, Inc.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith And Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith And Nephew Suture Anchors - Tag Bioraptor Suture Anchor 7209317, 7209318, Smith And Nephew Suture Anchors - Bioraptor 2.3 Pk Suture Anchor, Smith And Nephew Suture Anchors - Ost.

Pre-market Notification Details

• Device ID: K151105
• 510k Number: K151105
• Device Name: Smith And Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith And Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318, Smith And Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor, Smith And Nephew Suture Anchors - Ost
• Classification: Fastener, Fixation, Biodegradable, Soft Tissue
• Applicant: Smith & Nephew, Inc. 130 Forbes Boulevard Mansfield, MA 02048
• Contact: Katherine Marcaccio
• Correspondent: Katherine Marcaccio; Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810
• Product Code: MAI
• Subsequent Product Code: GAT
• Subsequent Product Code: HWC
• Subsequent Product Code: JDR
• Subsequent Product Code: MBI
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-04-24
• Decision Date: 2015-07-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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