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)

KMI CEMENT RESTRICTOR IMPLANT

K-Number: K061465 · 2006-10-05

ApplicantKinetikos Medical, Inc.
Decision Date2006-10-05
Product CodeJDK
Advisory CommitteeSU
DecisionUnknown

Device Summary

KMI CEMENT RESTRICTOR 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 2006-10-05 under 510(k) number K061465. The device is classified under product code JDK. It was reviewed by the SU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the KMI CEMENT RESTRICTOR IMPLANT?

KMI CEMENT RESTRICTOR IMPLANT is a medical device that received FDA 510(k) clearance on 2006-10-05. The listed applicant is Kinetikos Medical, Inc.. The 510(k) number is K061465.

When did KMI CEMENT RESTRICTOR IMPLANT receive FDA 510(k) clearance?

KMI CEMENT RESTRICTOR IMPLANT received FDA 510(k) clearance on 2006-10-05, under 510(k) number K061465.

Who is the listed applicant for KMI CEMENT RESTRICTOR 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 KMI CEMENT RESTRICTOR IMPLANT?

The FDA product code for KMI CEMENT RESTRICTOR IMPLANT is JDK.

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 IMPLANTK051611MBARESORB IMPLANTK041461KMI DISTAL VOLAR RADIUS PLATE SYSTEMK032806KATALYST RADIAL HEAD IMPLANTK040356KOMPRESSOR SCREW SYSTEMK024233KOMPRESSOR SCREW SYSTEM

View all 19 devices →

Related Devices (Code: JDK)

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.

K210062Mectaplug PE IIMedacta International S.A.K061698MODIFICATION TO LIFE SPINE CEMENT RESTRICTORLife SpineK060247LIFE SPINE CEMENT RESTRICTORLife SpineK060132SPINAL USA CEMENT RESTRICTOR SYSTEMSpinal USAK051371INTERBODY INNOVATIONS CEMENT RESTRICTORInterbody Innovations, LlpK051836SKELITE RESORBABLE CEMENT RESTRICTORMillenium Biologix, 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.

↑