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

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M7405708599	K170255	000
M7405705560	K170255	000
M7405706530	K170255	000
M7405706535	K170255	000
M7405706540	K170255	000
M7405706545	K170255	000
M7405706550	K170255	000
M7405706555	K170255	000
M7405706560	K170255	000
M7405705555	K170255	000
M7405705550	K170255	000
M7405705035	K170255	000
M7405705040	K170255	000
M7405705045	K170255	000
M7405705050	K170255	000
M7405705530	K170255	000
M7405705535	K170255	000
M7405705540	K170255	000
M7405705545	K170255	000
M7405706565	K170255	000
M7405707530	K170255	000
M7405708545	K170255	000
M7405708550	K170255	000
M7405708555	K170255	000
M7405708560	K170255	000
M7405708565	K170255	000
M7405708570	K170255	000
M7405708580	K170255	000
M7405708590	K170255	000
M7405708540	K170255	000
M7405708535	K170255	000
M7405707535	K170255	000
M7405707540	K170255	000
M7405707545	K170255	000
M7405707550	K170255	000
M7405707555	K170255	000
M7405707560	K170255	000
M7405707565	K170255	000
M7405708530	K170255	000
M7405705030	K170255	000