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: K161694
• 510k Number: K161694
• Device Name: Threshold™ Pedicular Fixation System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: Spineology Inc. 7800 3rd Street N, Suite 600 St. Paul, MN 55128 -5455
• Contact: Jacqueline A. Hauge
• Correspondent: Jacqueline A. Hauge; Spineology Inc. 7800 3rd Street N, Suite 600 St. Paul, MN 55128 -5455
• 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: 2016-06-20
• Decision Date: 2016-07-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M7405505030	K161694	000
M7405508530	K161694	000
M7405507565	K161694	000
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M7405515030	K161694	000
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M7405515050	K161694	000
M7405515045	K161694	000
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M7405516550	K161694	000
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M7405516530	K161694	000
M7405515560	K161694	000
M7405518599	K161694	000