THE TOSCA ANTERIOR CERVICAL PLATE SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

SIGNUS MEDIZINTECHNIK GMBH

The following data is part of a premarket notification filed by Signus Medizintechnik Gmbh with the FDA for The Tosca Anterior Cervical Plate System.

Pre-market Notification Details

• Device ID: K043082
• 510k Number: K043082
• Device Name: THE TOSCA ANTERIOR CERVICAL PLATE SYSTEM
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: SIGNUS MEDIZINTECHNIK GMBH 4050 OLSON MEMORIAL HWY SUITE 350 Minneapolis, MN 55422
• Contact: Tracy L Gray
• Correspondent: Tracy L Gray; SIGNUS MEDIZINTECHNIK GMBH 4050 OLSON MEMORIAL HWY SUITE 350 Minneapolis, MN 55422
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-11-08
• Decision Date: 2004-11-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04047844002421	K043082	000
04047844002544	K043082	000
04047844002551	K043082	000
04047844002568	K043082	000
04047844002575	K043082	000
04047844002582	K043082	000
04047844002599	K043082	000
04047844002605	K043082	000
04047844002612	K043082	000
04047844002629	K043082	000
04047844002537	K043082	000
04047844002520	K043082	000
04047844002438	K043082	000
04047844002445	K043082	000
04047844002452	K043082	000
04047844002469	K043082	000
04047844002476	K043082	000
04047844002483	K043082	000
04047844002490	K043082	000
04047844002506	K043082	000
04047844002513	K043082	000
04047844002636	K043082	000
04047844002643	K043082	000
04047844002650	K043082	000
04047844002773	K043082	000
04047844002780	K043082	000
04047844002797	K043082	000
04047844002803	K043082	000
04047844002810	K043082	000
04047844002827	K043082	000
04047844002834	K043082	000
04047844002841	K043082	000
04047844002858	K043082	000
04047844002766	K043082	000
04047844006313	K043082	000
04047844002667	K043082	000
04047844002674	K043082	000
04047844002681	K043082	000
04047844002698	K043082	000
04047844002704	K043082	000
04047844002728	K043082	000
04047844002735	K043082	000
04047844002742	K043082	000
04047844002759	K043082	000
04047844002711	K043082	000