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FDA 510(k)

AEGIS & AEGIS II SPINAL SYSTEM

K-Number: K092076 · 2010-04-02

ApplicantCorentec Co., Ltd.
Decision Date2010-04-02
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AEGIS & AEGIS II SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Corentec Co., Ltd.. It received FDA 510(k) clearance on 2010-04-02 under 510(k) number K092076. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AEGIS & AEGIS II SPINAL SYSTEM?

AEGIS & AEGIS II SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2010-04-02. The listed applicant is Corentec Co., Ltd.. The 510(k) number is K092076.

When did AEGIS & AEGIS II SPINAL SYSTEM receive FDA 510(k) clearance?

AEGIS & AEGIS II SPINAL SYSTEM received FDA 510(k) clearance on 2010-04-02, under 510(k) number K092076.

Who is the listed applicant for AEGIS & AEGIS II SPINAL SYSTEM?

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

What is the FDA product code for AEGIS & AEGIS II SPINAL SYSTEM?

The FDA product code for AEGIS & AEGIS II SPINAL SYSTEM is MNI.

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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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