BIORAPTOR 2.3 PK SUTURE ANCHOR

Fastener, Fixation, Nondegradable, Soft Tissue

SMITH & NEPHEW INC., ENDOSCOPY DIVISION

The following data is part of a premarket notification filed by Smith & Nephew Inc., Endoscopy Division with the FDA for Bioraptor 2.3 Pk Suture Anchor.

Pre-market Notification Details

• Device ID: K071586
• 510k Number: K071586
• Device Name: BIORAPTOR 2.3 PK SUTURE ANCHOR
• Classification: Fastener, Fixation, Nondegradable, Soft Tissue
• Applicant: SMITH & NEPHEW INC., ENDOSCOPY DIVISION 150 MINUTEMAN RD. Andover, MA 01810
• Contact: Julie Acker
• Correspondent: Julie Acker; SMITH & NEPHEW INC., ENDOSCOPY DIVISION 150 MINUTEMAN RD. Andover, MA 01810
• Product Code: MBI
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-06-11
• Decision Date: 2007-08-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03596010595096	K071586	000
03596010595089	K071586	000
03596010595072	K071586	000
03596010607577	K071586	000
03596010607560	K071586	000
03596010619082	K071586	000