UNI-T SPINAL SYSTEM

Orthosis, Spinal Pedicle Fixation

SPINEVISION, INC.

The following data is part of a premarket notification filed by Spinevision, Inc. with the FDA for Uni-t Spinal System.

Pre-market Notification Details

• Device ID: K013301
• 510k Number: K013301
• Device Name: UNI-T SPINAL SYSTEM
• Classification: Orthosis, Spinal Pedicle Fixation
• Applicant: SPINEVISION, INC. 3003 SUMMIT BLVD.; STE 1500 Atlanta, GA 30319
• Contact: Lynnette Whitaker
• Correspondent: Lynnette Whitaker; SPINEVISION, INC. 3003 SUMMIT BLVD.; STE 1500 Atlanta, GA 30319
• Product Code: MNI
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-10-03
• Decision Date: 2002-02-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03663136006369	K013301	000
03663136006086	K013301	000
03663136006062	K013301	000
03663136005706	K013301	000
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03663136006390	K013301	000