PLUS PIVOT LINK UNIVERSAL SYSTEM

Orthosis, Spinal Pedicle Fixation

SPINEVISION, INC.

The following data is part of a premarket notification filed by Spinevision, Inc. with the FDA for Plus Pivot Link Universal System.

Pre-market Notification Details

• Device ID: K033508
• 510k Number: K033508
• Device Name: PLUS PIVOT LINK UNIVERSAL SYSTEM
• Classification: Orthosis, Spinal Pedicle Fixation
• Applicant: SPINEVISION, INC. 3003 SUMMIT BLVD. SUITE 1400 Atlanta, GA 30319
• Contact: Lynnette Whitaker
• Correspondent: Lynnette Whitaker; SPINEVISION, INC. 3003 SUMMIT BLVD. SUITE 1400 Atlanta, GA 30319
• Product Code: MNI
• Subsequent Product Code: KWP
• Subsequent Product Code: KWQ
• Subsequent Product Code: MNH
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-11-06
• Decision Date: 2004-01-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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