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FDA 510(k)

DePuy CONDUIT LLIF Angled Inserters

K-Number: K212823 · 2021-11-01

ApplicantEnztec Limited
Decision Date2021-11-01
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DePuy CONDUIT LLIF Angled Inserters is the device name listed in this FDA 510(k) record. The listed applicant is Enztec Limited. It received FDA 510(k) clearance on 2021-11-01 under 510(k) number K212823. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DePuy CONDUIT LLIF Angled Inserters?

DePuy CONDUIT LLIF Angled Inserters is a medical device that received FDA 510(k) clearance on 2021-11-01. The listed applicant is Enztec Limited. The 510(k) number is K212823.

When did DePuy CONDUIT LLIF Angled Inserters receive FDA 510(k) clearance?

DePuy CONDUIT LLIF Angled Inserters received FDA 510(k) clearance on 2021-11-01, under 510(k) number K212823.

Who is the listed applicant for DePuy CONDUIT LLIF Angled Inserters?

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

What is the FDA product code for DePuy CONDUIT LLIF Angled Inserters?

The FDA product code for DePuy CONDUIT LLIF Angled Inserters is MAX.

Other records listing Enztec Limited 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.

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Related Devices (Code: MAX)

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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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