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FDA 510(k)

DETAX IMPLANTLINK SEMI

K-Number: K100247 · 2010-07-23

ApplicantDetax GmbH & Co. KG
Decision Date2010-07-23
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DETAX IMPLANTLINK SEMI is the device name listed in this FDA 510(k) record. The listed applicant is Detax GmbH & Co. KG. It received FDA 510(k) clearance on 2010-07-23 under 510(k) number K100247. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DETAX IMPLANTLINK SEMI?

DETAX IMPLANTLINK SEMI is a medical device that received FDA 510(k) clearance on 2010-07-23. The listed applicant is Detax GmbH & Co. KG. The 510(k) number is K100247.

When did DETAX IMPLANTLINK SEMI receive FDA 510(k) clearance?

DETAX IMPLANTLINK SEMI received FDA 510(k) clearance on 2010-07-23, under 510(k) number K100247.

Who is the listed applicant for DETAX IMPLANTLINK SEMI?

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

What is the FDA product code for DETAX IMPLANTLINK SEMI?

The FDA product code for DETAX IMPLANTLINK SEMI is EMA.

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Other records listing Detax GmbH & Co. KG as applicant

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Related Devices (Code: EMA)

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

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

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