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FDA 510(k)

TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5

K-Number: K073159 · 2008-07-23

ApplicantTrauson (Jiangsu) Medical Instrument Co., Ltd.
Decision Date2008-07-23
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5 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 2008-07-23 under 510(k) number K073159. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5?

TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5 is a medical device that received FDA 510(k) clearance on 2008-07-23. The listed applicant is Trauson (Jiangsu) Medical Instrument Co., Ltd.. The 510(k) number is K073159.

When did TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5 receive FDA 510(k) clearance?

TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5 received FDA 510(k) clearance on 2008-07-23, under 510(k) number K073159.

Who is the listed applicant for TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5?

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 BONE SCREW, MODELS HA 3.5 AND 4.5?

The FDA product code for TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5 is HWC. This falls under the Cardiovascular category.

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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)K081230TRAUSON INTRAMEDULLARY NAILK073432TRAUSON BONE PLATE

Related Devices (Code: HWC)

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

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