VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS

Spinal Vertebral Body Replacement Device

ORTHO DEVELOPMENT CORP.

The following data is part of a premarket notification filed by Ortho Development Corp. with the FDA for Vusion Ts, Ps, And Cs Partial Vertebral Body Replacements.

Pre-market Notification Details

• Device ID: K062666
• 510k Number: K062666
• Device Name: VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS
• Classification: Spinal Vertebral Body Replacement Device
• Applicant: ORTHO DEVELOPMENT CORP. 12187 SOUTH BUSINESS PARK DR. Draper, UT 84020
• Contact: William J Griffin
• Correspondent: William J Griffin; ORTHO DEVELOPMENT CORP. 12187 SOUTH BUSINESS PARK DR. Draper, UT 84020
• Product Code: MQP
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-09-07
• Decision Date: 2007-01-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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