FORZA® XP Expandable Spacer System

Intervertebral Fusion Device With Bone Graft, Lumbar

Orthofix Inc.

The following data is part of a premarket notification filed by Orthofix Inc. with the FDA for Forza® Xp Expandable Spacer System.

Pre-market Notification Details

• Device ID: K172696
• 510k Number: K172696
• Device Name: FORZA® XP Expandable Spacer System
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: Orthofix Inc. 3451 Plano Parkway Lewisville, TX 75056
• Contact: Natalia Volosen
• Correspondent: Natalia Volosen; Orthofix Inc. 3451 Plano Parkway Lewisville, TX 75056
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-09-07
• Decision Date: 2018-01-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
18257200122462	K172696	000
18257200122684	K172696	000
18257200122707	K172696	000
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18257200122806	K172696	000
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18257200123025	K172696	000
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18257200142613	K172696	000