ISS INTEGRATED SPINE SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

ORTHO DEVELOPMENT CORP.

The following data is part of a premarket notification filed by Ortho Development Corp. with the FDA for Iss Integrated Spine System.

Pre-market Notification Details

• Device ID: K061524
• 510k Number: K061524
• Device Name: ISS INTEGRATED SPINE SYSTEM
• Classification: Orthosis, Spondylolisthesis Spinal Fixation
• 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: MNH
• Subsequent Product Code: KWP
• Subsequent Product Code: MNI
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-06-02
• Decision Date: 2006-09-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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