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FDA 510(k)

TRAUSON INTRAMEDULLARY NAIL

K-Number: K081230 · 2009-01-13

ApplicantTrauson (Jiangsu) Medical Instrument Co., Ltd.
Decision Date2009-01-13
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRAUSON INTRAMEDULLARY NAIL is the device name listed in this FDA 510(k) record. The listed applicant is Trauson (Jiangsu) Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2009-01-13 under 510(k) number K081230. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRAUSON INTRAMEDULLARY NAIL?

TRAUSON INTRAMEDULLARY NAIL is a medical device that received FDA 510(k) clearance on 2009-01-13. The listed applicant is Trauson (Jiangsu) Medical Instrument Co., Ltd.. The 510(k) number is K081230.

When did TRAUSON INTRAMEDULLARY NAIL receive FDA 510(k) clearance?

TRAUSON INTRAMEDULLARY NAIL received FDA 510(k) clearance on 2009-01-13, under 510(k) number K081230.

Who is the listed applicant for TRAUSON INTRAMEDULLARY NAIL?

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

What is the FDA product code for TRAUSON INTRAMEDULLARY NAIL?

The FDA product code for TRAUSON INTRAMEDULLARY NAIL is HSB.

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Other records listing Trauson (Jiangsu) Medical Instrument Co., Ltd. as applicant

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.

K082617TRAUSON GENERAL SPINAL SYSTEM (GSS)K073432TRAUSON BONE PLATEK073159TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5

Related Devices (Code: HSB)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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