GRAVITY™ Syndesmosis LP

Washer, Bolt Nut

WRIGHT MEDICAL TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Gravity™ Syndesmosis Lp.

Pre-market Notification Details

• Device ID: K170249
• 510k Number: K170249
• Device Name: GRAVITY™ Syndesmosis LP
• Classification: Washer, Bolt Nut
• 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: HTN
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-01-27
• Decision Date: 2017-06-30
• Summary: summary