CASCADIA Interbody System

Intervertebral Fusion Device With Integrated Fixation, Lumbar

K2M

The following data is part of a premarket notification filed by K2m with the FDA for Cascadia Interbody System.

Pre-market Notification Details

• Device ID: K172941
• 510k Number: K172941
• Device Name: CASCADIA Interbody System
• Classification: Intervertebral Fusion Device With Integrated Fixation, Lumbar
• Applicant: K2M 600 Hope Parkway SE Leesburg, VA 20175
• Contact: Nancy Giezen
• Correspondent: Nancy Giezen; K2M 600 Hope Parkway SE Leesburg, VA 20175
• Product Code: OVD
• Subsequent Product Code: MAX
• Subsequent Product Code: ODP
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-09-26
• Decision Date: 2018-02-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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