GRAVITY™ Soft Tissue Repair System

Suture, Nonabsorbable, Synthetic, Polyethylene

Wright Medical Technology, Inc.

The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Gravity™ Soft Tissue Repair System.

Pre-market Notification Details

• Device ID: K170642
• 510k Number: K170642
• Device Name: GRAVITY™ Soft Tissue Repair System
• Classification: Suture, Nonabsorbable, Synthetic, Polyethylene
• Applicant: Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117
• Contact: Michael Mullins
• Correspondent: Michael Mullins; Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117
• Product Code: GAT
• CFR Regulation Number: 878.5000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-03-02
• Decision Date: 2017-08-22
• Summary: summary