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FDA 510(k)

INION OTPS BIODEGRADABLE PIN

K-Number: K031712 · 2003-08-28

ApplicantInion , Ltd.
Decision Date2003-08-28
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INION OTPS BIODEGRADABLE PIN is the device name listed in this FDA 510(k) record. The listed applicant is Inion , Ltd.. It received FDA 510(k) clearance on 2003-08-28 under 510(k) number K031712. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INION OTPS BIODEGRADABLE PIN?

INION OTPS BIODEGRADABLE PIN is a medical device that received FDA 510(k) clearance on 2003-08-28. The listed applicant is Inion , Ltd.. The 510(k) number is K031712.

When did INION OTPS BIODEGRADABLE PIN receive FDA 510(k) clearance?

INION OTPS BIODEGRADABLE PIN received FDA 510(k) clearance on 2003-08-28, under 510(k) number K031712.

Who is the listed applicant for INION OTPS BIODEGRADABLE PIN?

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 PIN?

The FDA product code for INION OTPS BIODEGRADABLE PIN is HTY.

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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: HTY)

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.

K262722Primal K-Wire (P99-193-1410)Paragon 28, Inc.K253325ZipToe™ Hammertoe Fusion SystemToetal SolutionsK252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.K250315RONAVIS – FX (FX-001)AIRS, Inc.K251362PediFlex™ Flexible Nail SystemOrthoPediatrics Corp.K250646Impact PEEK Union Nail SystemNvision Biomedical Technologies

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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