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)

PRESSURIZING/SCAVENGING ACRYLIC CEMENT

K-Number: K840046 · 1984-02-09

ApplicantPrecision Medical Devices, Inc.
Decision Date1984-02-09
Product CodeKIH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PRESSURIZING/SCAVENGING ACRYLIC CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Precision Medical Devices, Inc.. It received FDA 510(k) clearance on 1984-02-09 under 510(k) number K840046. The device is classified under product code KIH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRESSURIZING/SCAVENGING ACRYLIC CEMENT?

PRESSURIZING/SCAVENGING ACRYLIC CEMENT is a medical device that received FDA 510(k) clearance on 1984-02-09. The listed applicant is Precision Medical Devices, Inc.. The 510(k) number is K840046.

When did PRESSURIZING/SCAVENGING ACRYLIC CEMENT receive FDA 510(k) clearance?

PRESSURIZING/SCAVENGING ACRYLIC CEMENT received FDA 510(k) clearance on 1984-02-09, under 510(k) number K840046.

Who is the listed applicant for PRESSURIZING/SCAVENGING ACRYLIC CEMENT?

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

What is the FDA product code for PRESSURIZING/SCAVENGING ACRYLIC CEMENT?

The FDA product code for PRESSURIZING/SCAVENGING ACRYLIC CEMENT is KIH.

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 Precision Medical Devices, 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.

K863854P.M.D. INTRAMEDULLARY CEMENT RESTRICTOR PLUGK840856MODULAR CONSTRUCT FRAME EXTERNAL FIXA

Related Devices (Code: KIH)

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.

K042591SMARTMIX PRE-FILLED MIXING SYSTEMDePuy Orthopaedics, Inc.K943906P.F.C. CEMENT PRESSURIZING SYSTEMJohnson & Johnson Professionals, Inc.K897134CMW CEMENT PRESSURISATION SYSTEMDentsply Intl.K851881ORTHOPEADIC CEMENT DELIVERY SYSTEMDentsply Intl.K833675BRIGHAM TIBIAL CEMENT PRESSURIZERHowmedica Corp.K811317HOWMEDICA FEMORAL PRESSURING SEALHowmedica Corp.

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.

↑