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FDA 510(k)

TOSCA II ANTERIOR CERVICAL PLATE SYSTEM

K-Number: K080815 · 2008-04-23

ApplicantSignus Medizintechnik GmbH
Decision Date2008-04-23
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TOSCA II ANTERIOR CERVICAL PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Signus Medizintechnik GmbH. It received FDA 510(k) clearance on 2008-04-23 under 510(k) number K080815. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOSCA II ANTERIOR CERVICAL PLATE SYSTEM?

TOSCA II ANTERIOR CERVICAL PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2008-04-23. The listed applicant is Signus Medizintechnik GmbH. The 510(k) number is K080815.

When did TOSCA II ANTERIOR CERVICAL PLATE SYSTEM receive FDA 510(k) clearance?

TOSCA II ANTERIOR CERVICAL PLATE SYSTEM received FDA 510(k) clearance on 2008-04-23, under 510(k) number K080815.

Who is the listed applicant for TOSCA II ANTERIOR CERVICAL PLATE SYSTEM?

The FDA 510(k) record lists Signus Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOSCA II ANTERIOR CERVICAL PLATE SYSTEM?

The FDA product code for TOSCA II ANTERIOR CERVICAL PLATE SYSTEM is KWQ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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