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FDA 510(k)

LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM

K-Number: K131878 · 2013-08-23

ApplicantMedyssey USA, Inc.
Decision Date2013-08-23
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medyssey USA, Inc.. It received FDA 510(k) clearance on 2013-08-23 under 510(k) number K131878. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM?

LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2013-08-23. The listed applicant is Medyssey USA, Inc.. The 510(k) number is K131878.

When did LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM receive FDA 510(k) clearance?

LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM received FDA 510(k) clearance on 2013-08-23, under 510(k) number K131878.

Who is the listed applicant for LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM?

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

What is the FDA product code for LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM?

The FDA product code for LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM is NKB.

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Related Devices (Code: NKB)

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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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