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FDA 510(k)

INTEGRA IMMOBILIZATION SYSTEM

K-Number: K050888 · 2005-05-23

ApplicantDiacor, Inc.
Decision Date2005-05-23
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INTEGRA IMMOBILIZATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Diacor, Inc.. It received FDA 510(k) clearance on 2005-05-23 under 510(k) number K050888. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTEGRA IMMOBILIZATION SYSTEM?

INTEGRA IMMOBILIZATION SYSTEM is a medical device that received FDA 510(k) clearance on 2005-05-23. The listed applicant is Diacor, Inc.. The 510(k) number is K050888.

When did INTEGRA IMMOBILIZATION SYSTEM receive FDA 510(k) clearance?

INTEGRA IMMOBILIZATION SYSTEM received FDA 510(k) clearance on 2005-05-23, under 510(k) number K050888.

Who is the listed applicant for INTEGRA IMMOBILIZATION SYSTEM?

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

What is the FDA product code for INTEGRA IMMOBILIZATION SYSTEM?

The FDA product code for INTEGRA IMMOBILIZATION SYSTEM is IYE.

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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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