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FDA 510(k)

INION TRINION BIODEGRADABLE MENISCUS SCREW

K-Number: K031714 · 2004-08-16

ApplicantInion , Ltd.
Decision Date2004-08-16
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INION TRINION BIODEGRADABLE MENISCUS SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Inion , Ltd.. It received FDA 510(k) clearance on 2004-08-16 under 510(k) number K031714. 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 INION TRINION BIODEGRADABLE MENISCUS SCREW?

INION TRINION BIODEGRADABLE MENISCUS SCREW is a medical device that received FDA 510(k) clearance on 2004-08-16. The listed applicant is Inion , Ltd.. The 510(k) number is K031714.

When did INION TRINION BIODEGRADABLE MENISCUS SCREW receive FDA 510(k) clearance?

INION TRINION BIODEGRADABLE MENISCUS SCREW received FDA 510(k) clearance on 2004-08-16, under 510(k) number K031714.

Who is the listed applicant for INION TRINION BIODEGRADABLE MENISCUS SCREW?

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

What is the FDA product code for INION TRINION BIODEGRADABLE MENISCUS SCREW?

The FDA product code for INION TRINION BIODEGRADABLE MENISCUS SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing Inion , 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.

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Related Devices (Code: HWC)

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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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