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)

H-220 PRESS-FIT ACETABULAR CUP SYSTEM

K-Number: K926134 · 1993-10-15

ApplicantImplex Corp.
Decision Date1993-10-15
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

H-220 PRESS-FIT ACETABULAR CUP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Implex Corp.. It received FDA 510(k) clearance on 1993-10-15 under 510(k) number K926134. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the H-220 PRESS-FIT ACETABULAR CUP SYSTEM?

H-220 PRESS-FIT ACETABULAR CUP SYSTEM is a medical device that received FDA 510(k) clearance on 1993-10-15. The listed applicant is Implex Corp.. The 510(k) number is K926134.

When did H-220 PRESS-FIT ACETABULAR CUP SYSTEM receive FDA 510(k) clearance?

H-220 PRESS-FIT ACETABULAR CUP SYSTEM received FDA 510(k) clearance on 1993-10-15, under 510(k) number K926134.

Who is the listed applicant for H-220 PRESS-FIT ACETABULAR CUP SYSTEM?

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

What is the FDA product code for H-220 PRESS-FIT ACETABULAR CUP SYSTEM?

The FDA product code for H-220 PRESS-FIT ACETABULAR CUP SYSTEM is MEH.

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 Implex 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.

K051978TRABECULAR METAL VERTEBRAL BODY REPLACEMENTK051196TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1K040487TRABECULAR METAL KNEE SYSTEM AUGMENTSK040630TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZK040756THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXXK031962NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS

View all 65 devices →

Related Devices (Code: MEH)

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.

K261576Icona Hip StemCorin, Ltd.K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KGK251166Mfinity Femoral SystemMedacta International S.A.K251052Trivicta® Hip StemOrtho Development Corp.K242315Resolve Modular Revision Hip StemUnited Orthopedic CorporationK243839Alteon® HA Femoral StemsExactech, 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.

↑