Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

INION OTPS BIODEGRADABLE FIXATON SYSTEM

K-Number: K030900 · 2003-06-19

ApplicantInion , Ltd.
Decision Date2003-06-19
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INION OTPS BIODEGRADABLE FIXATON 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 2003-06-19 under 510(k) number K030900. 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 FIXATON SYSTEM?

INION OTPS BIODEGRADABLE FIXATON SYSTEM is a medical device that received FDA 510(k) clearance on 2003-06-19. The listed applicant is Inion , Ltd.. The 510(k) number is K030900.

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

INION OTPS BIODEGRADABLE FIXATON SYSTEM received FDA 510(k) clearance on 2003-06-19, under 510(k) number K030900.

Who is the listed applicant for INION OTPS BIODEGRADABLE FIXATON 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 FIXATON SYSTEM?

The FDA product code for INION OTPS BIODEGRADABLE FIXATON SYSTEM is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 23 devices →

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.

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps OrthoK261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower OrthopedK262344Large Compression ScrewsTriMed, Inc.

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.

↑