MIS Z-Pedicle Screw System

Thoracolumbosacral Pedicle Screw System

Z-Medical GmbH & Co. KG

The following data is part of a premarket notification filed by Z-medical Gmbh & Co. Kg with the FDA for Mis Z-pedicle Screw System.

Pre-market Notification Details

• Device ID: K143200
• 510k Number: K143200
• Device Name: MIS Z-Pedicle Screw System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: Z-Medical GmbH & Co. KG Gansacker 38 Tuttlingen, DE
• Contact: Alexander Henninger
• Correspondent: Alexander Henninger; Z-Medical GmbH & Co. KG Gansacker 38 Tuttlingen, DE
• Product Code: NKB
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-11-06
• Decision Date: 2015-02-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04250337104230	K143200	000
04250337104414	K143200	000
04250337104421	K143200	000
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