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FDA 510(k)

SPI ELEMENT PLATFORM O 4.0 MM

K-Number: K070007 · 2007-01-10

ApplicantThommen Medical AG
Decision Date2007-01-10
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SPI ELEMENT PLATFORM O 4.0 MM is the device name listed in this FDA 510(k) record. The listed applicant is Thommen Medical AG. It received FDA 510(k) clearance on 2007-01-10 under 510(k) number K070007. 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 SPI ELEMENT PLATFORM O 4.0 MM?

SPI ELEMENT PLATFORM O 4.0 MM is a medical device that received FDA 510(k) clearance on 2007-01-10. The listed applicant is Thommen Medical AG. The 510(k) number is K070007.

When did SPI ELEMENT PLATFORM O 4.0 MM receive FDA 510(k) clearance?

SPI ELEMENT PLATFORM O 4.0 MM received FDA 510(k) clearance on 2007-01-10, under 510(k) number K070007.

Who is the listed applicant for SPI ELEMENT PLATFORM O 4.0 MM?

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

What is the FDA product code for SPI ELEMENT PLATFORM O 4.0 MM?

The FDA product code for SPI ELEMENT PLATFORM O 4.0 MM is DZE.

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Other records listing Thommen Medical AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171795Thommen Implant SystemK160244VARIOuniteK151984Thommen Milling Abutment for CAD/CAMK121334VARIOECOK111984SPI VARIO ANGLED ABUTMENTK102804SPI TITANIUM BASE FOR CAD/CAM

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Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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