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FDA 510(k)

IRENE Locking Compression Plate System

K-Number: K151508 · 2016-02-25

ApplicantTianjin Zhengtian Medical Instrument Co., Ltd.
Decision Date2016-02-25
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IRENE Locking Compression Plate System is a medical device manufactured by Tianjin Zhengtian Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2016-02-25 under approval number K151508. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRENE Locking Compression Plate System?

IRENE Locking Compression Plate System is a medical device that received FDA 510(k) clearance on 2016-02-25. It is manufactured by Tianjin Zhengtian Medical Instrument Co., Ltd.. The 510(k) number is K151508.

When was IRENE Locking Compression Plate System approved by the FDA?

IRENE Locking Compression Plate System received FDA 510(k) clearance on 2016-02-25, under approval number K151508.

What company makes IRENE Locking Compression Plate System?

IRENE Locking Compression Plate System is manufactured by Tianjin Zhengtian Medical Instrument Co., Ltd..

What is the FDA product code for IRENE Locking Compression Plate System?

The FDA product code for IRENE Locking Compression Plate System is HRS.

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Other Devices by Tianjin Zhengtian Medical Instrument Co., Ltd.

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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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