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FDA 510(k)

ITI TRANSVERSAL SCREWING SYSTEM

K-Number: K943720 · 1995-03-24

ApplicantThe Straumann Co.
Decision Date1995-03-24
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ITI TRANSVERSAL SCREWING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is The Straumann Co.. It received FDA 510(k) clearance on 1995-03-24 under 510(k) number K943720. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ITI TRANSVERSAL SCREWING SYSTEM?

ITI TRANSVERSAL SCREWING SYSTEM is a medical device that received FDA 510(k) clearance on 1995-03-24. The listed applicant is The Straumann Co.. The 510(k) number is K943720.

When did ITI TRANSVERSAL SCREWING SYSTEM receive FDA 510(k) clearance?

ITI TRANSVERSAL SCREWING SYSTEM received FDA 510(k) clearance on 1995-03-24, under 510(k) number K943720.

Who is the listed applicant for ITI TRANSVERSAL SCREWING SYSTEM?

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

What is the FDA product code for ITI TRANSVERSAL SCREWING SYSTEM?

The FDA product code for ITI TRANSVERSAL SCREWING SYSTEM is DZE.

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Other records listing The Straumann Co. as applicant

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Related Devices (Code: DZE)

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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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