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)

CEMENT RESTRICTOR

K-Number: K840413 · 1984-03-05

ApplicantAmerican Ortomed Corp.
Decision Date1984-03-05
Product CodeJDK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CEMENT RESTRICTOR is the device name listed in this FDA 510(k) record. The listed applicant is American Ortomed Corp.. It received FDA 510(k) clearance on 1984-03-05 under 510(k) number K840413. The device is classified under product code JDK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEMENT RESTRICTOR?

CEMENT RESTRICTOR is a medical device that received FDA 510(k) clearance on 1984-03-05. The listed applicant is American Ortomed Corp.. The 510(k) number is K840413.

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

CEMENT RESTRICTOR received FDA 510(k) clearance on 1984-03-05, under 510(k) number K840413.

Who is the listed applicant for CEMENT RESTRICTOR?

The FDA 510(k) record lists American Ortomed Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CEMENT RESTRICTOR?

The FDA product code for CEMENT RESTRICTOR 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 American Ortomed Corp. 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.

K842518UNILOC-CEMENTLESS & SELF TAP ACETABULARK842466TITANIUM MITTELMEIER TYPE ACETABULARK842465UNILOCK820719THE ICR KNEEK780497SPHERISTEM TOTAL HIP PROSTHESIS

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.K061465KMI CEMENT RESTRICTOR IMPLANTKinetikos Medical, Inc.K061698MODIFICATION TO LIFE SPINE CEMENT RESTRICTORLife SpineK060247LIFE SPINE CEMENT RESTRICTORLife SpineK060132SPINAL USA CEMENT RESTRICTOR SYSTEMSpinal USAK051371INTERBODY INNOVATIONS CEMENT RESTRICTORInterbody Innovations, Llp

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.

↑