VUSION CS PLUS

Intervertebral Fusion Device With Bone Graft, Cervical

ORTHO DEVELOPMENT CORP.

The following data is part of a premarket notification filed by Ortho Development Corp. with the FDA for Vusion Cs Plus.

Pre-market Notification Details

• Device ID: K122588
• 510k Number: K122588
• Device Name: VUSION CS PLUS
• Classification: Intervertebral Fusion Device With Bone Graft, Cervical
• Applicant: ORTHO DEVELOPMENT CORP. 12187 SOUTH BUSINESS PARK DR. Draper, UT 84020
• Contact: Tom Haueter
• Correspondent: Tom Haueter; ORTHO DEVELOPMENT CORP. 12187 SOUTH BUSINESS PARK DR. Draper, UT 84020
• Product Code: ODP
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-08-24
• Decision Date: 2013-06-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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