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FDA 510(k)

Fixone Biocomposite Interference Screw

K-Number: K193497 · 2021-01-05

ApplicantAju Pharm Co., Ltd.
Decision Date2021-01-05
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Fixone Biocomposite Interference Screw is the device name listed in this FDA 510(k) record. The listed applicant is Aju Pharm Co., Ltd.. It received FDA 510(k) clearance on 2021-01-05 under 510(k) number K193497. 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 Fixone Biocomposite Interference Screw?

Fixone Biocomposite Interference Screw is a medical device that received FDA 510(k) clearance on 2021-01-05. The listed applicant is Aju Pharm Co., Ltd.. The 510(k) number is K193497.

When did Fixone Biocomposite Interference Screw receive FDA 510(k) clearance?

Fixone Biocomposite Interference Screw received FDA 510(k) clearance on 2021-01-05, under 510(k) number K193497.

Who is the listed applicant for Fixone Biocomposite Interference Screw?

The FDA 510(k) record lists Aju Pharm Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fixone Biocomposite Interference Screw?

The FDA product code for Fixone Biocomposite Interference Screw is HWC. This falls under the Cardiovascular category.

Other records listing Aju Pharm Co., Ltd. as applicant

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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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