MIS SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

SPINE WAVE, INC.

The following data is part of a premarket notification filed by Spine Wave, Inc. with the FDA for Mis System.

Pre-market Notification Details

• Device ID: K100605
• 510k Number: K100605
• Device Name: MIS SYSTEM
• Classification: Orthosis, Spondylolisthesis Spinal Fixation
• Applicant: SPINE WAVE, INC. THREE ENTERPRISE DR. SUITE 210 Shelton, CT 06484
• Contact: Denise Duchene
• Correspondent: Denise Duchene; SPINE WAVE, INC. THREE ENTERPRISE DR. SUITE 210 Shelton, CT 06484
• Product Code: MNH
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-03-03
• Decision Date: 2010-06-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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