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FDA 510(k)

INTEGRA SL

K-Number: K062147 · 2006-10-20

ApplicantDirex Systems Corp.
Decision Date2006-10-20
Product CodeLNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INTEGRA SL is the device name listed in this FDA 510(k) record. The listed applicant is Direx Systems Corp.. It received FDA 510(k) clearance on 2006-10-20 under 510(k) number K062147. The device is classified under product code LNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTEGRA SL?

INTEGRA SL is a medical device that received FDA 510(k) clearance on 2006-10-20. The listed applicant is Direx Systems Corp.. The 510(k) number is K062147.

When did INTEGRA SL receive FDA 510(k) clearance?

INTEGRA SL received FDA 510(k) clearance on 2006-10-20, under 510(k) number K062147.

Who is the listed applicant for INTEGRA SL?

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

What is the FDA product code for INTEGRA SL?

The FDA product code for INTEGRA SL is LNS.

Related Clinical Trials

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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Other records listing Direx Systems Corp. 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.

K111947DUET MAGNAK102765PRONEXK072529TRACKPORTK071701TRACKLEAF-10K063482CROSSPLAN / ACCUSOFT-XL V.4.04K062032ACCUSOFT, ACCUSOFT XL

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Related Devices (Code: LNS)

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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