Threshold™ V2 Pedicular Fixation System

Thoracolumbosacral Pedicle Screw System

SPINEOLOGY INC.

The following data is part of a premarket notification filed by Spineology Inc. with the FDA for Threshold™ V2 Pedicular Fixation System.

Pre-market Notification Details

• Device ID: K170255
• 510k Number: K170255
• Device Name: Threshold™ V2 Pedicular Fixation System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: SPINEOLOGY INC. 7800 3RD STREET N SUITE 600 St. Paul, MN 55128
• Contact: Jacqueline Hauge
• Correspondent: Jacqueline A. Hauge; SPINEOLOGY INC. 7800 3RD STREET NORTH, SUITE 600 Saint Paul, MN 55128
• Product Code: NKB
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-01-27
• Decision Date: 2017-04-14
• Summary: summary