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FDA 510(k)

ARIX HAND LOCKING SYSTEM

K-Number: K132876 · 2013-12-18

ApplicantJeil Medical Corporation
Decision Date2013-12-18
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARIX HAND LOCKING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Jeil Medical Corporation. It received FDA 510(k) clearance on 2013-12-18 under 510(k) number K132876. 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 ARIX HAND LOCKING SYSTEM?

ARIX HAND LOCKING SYSTEM is a medical device that received FDA 510(k) clearance on 2013-12-18. The listed applicant is Jeil Medical Corporation. The 510(k) number is K132876.

When did ARIX HAND LOCKING SYSTEM receive FDA 510(k) clearance?

ARIX HAND LOCKING SYSTEM received FDA 510(k) clearance on 2013-12-18, under 510(k) number K132876.

Who is the listed applicant for ARIX HAND LOCKING SYSTEM?

The FDA 510(k) record lists Jeil Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARIX HAND LOCKING SYSTEM?

The FDA product code for ARIX HAND LOCKING SYSTEM is HRS.

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Related Devices (Code: HRS)

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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