GRYPHON® Anchors With DYNACORD™ Suture

Fastener, Fixation, Biodegradable, Soft Tissue

Medos International SARL

The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Gryphon® Anchors With Dynacord™ Suture.

Pre-market Notification Details

• Device ID: K181809
• 510k Number: K181809
• Device Name: GRYPHON® Anchors With DYNACORD™ Suture
• Classification: Fastener, Fixation, Biodegradable, Soft Tissue
• Applicant: Medos International SARL Chemin-Blanc 38, Case Postale Le Locle, CH Ch 2400
• Contact: Tatyana Korsunsky
• Correspondent: Tatyana Korsunsky; DePuy Mitek, A Johnson & Johnson Company 325 Paramount Drive Raynham, MA 02767
• Product Code: MAI
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-07-06
• Decision Date: 2018-08-03
• Summary: summary