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FDA 510(k)

INION OTPS BIODEGRADABLE MINI PLATING SYSTEM

K-Number: K023887 · 2003-05-30

ApplicantInion , Ltd.
Decision Date2003-05-30
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INION OTPS BIODEGRADABLE MINI PLATING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Inion , Ltd.. It received FDA 510(k) clearance on 2003-05-30 under 510(k) number K023887. 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 OTPS BIODEGRADABLE MINI PLATING SYSTEM?

INION OTPS BIODEGRADABLE MINI PLATING SYSTEM is a medical device that received FDA 510(k) clearance on 2003-05-30. The listed applicant is Inion , Ltd.. The 510(k) number is K023887.

When did INION OTPS BIODEGRADABLE MINI PLATING SYSTEM receive FDA 510(k) clearance?

INION OTPS BIODEGRADABLE MINI PLATING SYSTEM received FDA 510(k) clearance on 2003-05-30, under 510(k) number K023887.

Who is the listed applicant for INION OTPS BIODEGRADABLE MINI PLATING SYSTEM?

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 OTPS BIODEGRADABLE MINI PLATING SYSTEM?

The FDA product code for INION OTPS BIODEGRADABLE MINI PLATING SYSTEM 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.

K071810INION SPINAL GRAFT CONTAINMENT SYSTEMK063410INION CPS/OTPS FREEDOMPLATEK062617MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEMK060393INION HEXALON BIODEGRADABLE ACL/PCL SCREWK051821INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEMK052624INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE

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

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