ProMIS™ Fixation System

Thoracolumbosacral Pedicle Screw System

Premia Spine Ltd.

The following data is part of a premarket notification filed by Premia Spine Ltd. with the FDA for Promis™ Fixation System.

Pre-market Notification Details

• Device ID: K170061
• 510k Number: K170061
• Device Name: ProMIS™ Fixation System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: Premia Spine Ltd. 7 Giborey Israel Street Netanya, IL 4250407
• Contact: Kobi Arbus
• Correspondent: Janice M. Hogan; Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, PA 19103
• Product Code: NKB
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-01-06
• Decision Date: 2017-02-02
• Summary: summary