ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS

Fastener, Fixation, Nondegradable, Soft Tissue

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for All-suture Anchor Twist Drill For All-suture Anchors Inline Drill Guide For All-suture Anchors.

Pre-market Notification Details

• Device ID: K122059
• 510k Number: K122059
• Device Name: ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS
• Classification: Fastener, Fixation, Nondegradable, Soft Tissue
• Applicant: SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810
• Contact: Karin Desjardins
• Correspondent: Karin Desjardins; SMITH & NEPHEW, INC. 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: 2012-07-13
• Decision Date: 2013-03-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00885554030129	K122059	000