TANGORS POLYAXIAL SYSTEM

Thoracolumbosacral Pedicle Screw System

ULRICH GMBH & CO. KG

The following data is part of a premarket notification filed by Ulrich Gmbh & Co. Kg with the FDA for Tangors Polyaxial System.

Pre-market Notification Details

• Device ID: K052385
• 510k Number: K052385
• Device Name: TANGORS POLYAXIAL SYSTEM
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: ULRICH GMBH & CO. KG BUCHBRUNNENWEG 12 Ulm, DE D-89081
• Contact: Christoph Ulrich
• Correspondent: Christoph Ulrich; ULRICH GMBH & CO. KG BUCHBRUNNENWEG 12 Ulm, DE D-89081
• 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: 2005-08-30
• Decision Date: 2005-12-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04052536005734	K052385	000
04052536005932	K052385	000
04052536005949	K052385	000
04052536005956	K052385	000
04052536005963	K052385	000
04052536005970	K052385	000
04052536005987	K052385	000
04052536005994	K052385	000
04052536006007	K052385	000
04052536006014	K052385	000
04052536006076	K052385	000
04052536006083	K052385	000
04052536006090	K052385	000
04052536006106	K052385	000
04052536005925	K052385	000
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04052536005901	K052385	000
04052536005772	K052385	000
04052536005789	K052385	000
04052536005796	K052385	000
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04052536005826	K052385	000
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04052536005857	K052385	000
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04052536005871	K052385	000
04052536005888	K052385	000
04052536005895	K052385	000
04052536006113	K052385	000
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04052536006298	K052385	000
04052536006304	K052385	000
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04052536014002	K052385	000
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04052536014033	K052385	000
04052536014040	K052385	000
04052536014095	K052385	000
04052536014248	K052385	000
04052536014255	K052385	000
04052536014453	K052385	000
04052536006281	K052385	000
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04052536006243	K052385	000
04052536006250	K052385	000
04052536014460	K052385	000