FORTEZZA Spinal Stabilization System

Thoracolumbosacral Pedicle Screw System

OSSO SURGICAL

The following data is part of a premarket notification filed by Osso Surgical with the FDA for Fortezza Spinal Stabilization System.

Pre-market Notification Details

• Device ID: K162576
• 510k Number: K162576
• Device Name: FORTEZZA Spinal Stabilization System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: OSSO SURGICAL 2150 W 43RD ST Chicago, IL 60609
• Contact: Basheer Hassan
• Correspondent: Kimberly Strohkirch; MRC-X, LLC 3416 ROXEE RUN COVE Bartlett, TN 38133
• Product Code: NKB
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• Subsequent Product Code: OSH
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-09-15
• Decision Date: 2016-11-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850001740821	K162576	000
00850001740500	K162576	000
00850001740517	K162576	000
00850001740524	K162576	000
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