Threshold™ 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™ Pedicular Fixation System.

Pre-market Notification Details

• Device ID: K170251
• 510k Number: K170251
• Device Name: Threshold™ 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
• 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

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M7406806590	K170251	000
M7405500120	K170251	000
M7405500140	K170251	000
M7405500160	K170251	000
M7405500180	K170251	000
M7405500200	K170251	000
M7405501400	K170251	000
M7406800013	K170251	000
M7406800016	K170251	000
M7406801800	K170251	000
M7406802531	K170251	000
M7406803137	K170251	000
M7406803740	K170251	000
M7406804046	K170251	000
M7406804652	K170251	000
M7406805265	K170251	000
M7406805501	K170251	000
M7406805502	K170251	000
M7405500100	K170251	000