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)

KATALYST RADIAL HEAD IMPLANT

K-Number: K032806 · 2004-04-16

ApplicantKinetikos Medical, Inc.
Decision Date2004-04-16
Product CodeKWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KATALYST RADIAL HEAD IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Kinetikos Medical, Inc.. It received FDA 510(k) clearance on 2004-04-16 under 510(k) number K032806. The device is classified under product code KWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KATALYST RADIAL HEAD IMPLANT?

KATALYST RADIAL HEAD IMPLANT is a medical device that received FDA 510(k) clearance on 2004-04-16. The listed applicant is Kinetikos Medical, Inc.. The 510(k) number is K032806.

When did KATALYST RADIAL HEAD IMPLANT receive FDA 510(k) clearance?

KATALYST RADIAL HEAD IMPLANT received FDA 510(k) clearance on 2004-04-16, under 510(k) number K032806.

Who is the listed applicant for KATALYST RADIAL HEAD IMPLANT?

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

What is the FDA product code for KATALYST RADIAL HEAD IMPLANT?

The FDA product code for KATALYST RADIAL HEAD IMPLANT is KWI.

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 Kinetikos Medical, Inc. 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.

K061749ECLIPSE TOTAL ANKLE IMPLANTK061465KMI CEMENT RESTRICTOR IMPLANTK051611MBARESORB IMPLANTK041461KMI DISTAL VOLAR RADIUS PLATE SYSTEMK040356KOMPRESSOR SCREW SYSTEMK024233KOMPRESSOR SCREW SYSTEM

View all 19 devices →

Related Devices (Code: KWI)

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.

K260624Arthrex Radial Head Replacement SystemArthrex, Inc.K233592BioPoly Radial Head ImplantBioPoly, LLCK231188ALIGN Radial Head SystemSkeletal Dynamics, Inc.K213563DePuy Synthes Radial Head Replacement SystemDePuy SynthesK212872Avenger Radial Head SystemIn2bones USA, LLCK192754Avenger Radial Head SystemIn2bones USA, LLC

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.

↑