OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS

Fastener, Fixation, Biodegradable, Soft Tissue

SMITH & NEPHEW ENDOSCOPY, INC.

The following data is part of a premarket notification filed by Smith & Nephew Endoscopy, Inc. with the FDA for Osteoraptor Curved 2.3 Suture Anchors.

Pre-market Notification Details

• Device ID: K103309
• 510k Number: K103309
• Device Name: OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS
• Classification: Fastener, Fixation, Biodegradable, Soft Tissue
• Applicant: SMITH & NEPHEW ENDOSCOPY, INC. 150 Minuteman Road Andover, MA 01810
• Contact: Kathleen Solomon
• Correspondent: Kathleen Solomon; SMITH & NEPHEW ENDOSCOPY, INC. 150 Minuteman Road Andover, MA 01810
• Product Code: MAI
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-11-10
• Decision Date: 2011-02-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00885554028041	K103309	000
03596010656315	K103309	000