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)

CHARNLEY DESIGN HIP PROSTHESIS

K-Number: K801006 · 1980-05-20

ApplicantColmed, Ltd.
Decision Date1980-05-20
Product CodeJDG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CHARNLEY DESIGN HIP PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Colmed, Ltd.. It received FDA 510(k) clearance on 1980-05-20 under 510(k) number K801006. The device is classified under product code JDG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHARNLEY DESIGN HIP PROSTHESIS?

CHARNLEY DESIGN HIP PROSTHESIS is a medical device that received FDA 510(k) clearance on 1980-05-20. The listed applicant is Colmed, Ltd.. The 510(k) number is K801006.

When did CHARNLEY DESIGN HIP PROSTHESIS receive FDA 510(k) clearance?

CHARNLEY DESIGN HIP PROSTHESIS received FDA 510(k) clearance on 1980-05-20, under 510(k) number K801006.

Who is the listed applicant for CHARNLEY DESIGN HIP PROSTHESIS?

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

What is the FDA product code for CHARNLEY DESIGN HIP PROSTHESIS?

The FDA product code for CHARNLEY DESIGN HIP PROSTHESIS is JDG.

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 Colmed, Ltd. 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.

K811209JACOB WIRZ TRANSFIXATION PINK810636VARIODRAINK810117HALOGEN HEADLIGHT SYSTEMK801208HOLLOW BASKET TITANIUM DENTAL IMPLANTK800762PS3 TITANIUM SCREW DENTAL IMPLANTK792241PELIMIT

View all 7 devices →

Related Devices (Code: JDG)

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.

K212431Biomet Answer/Impact/Integral Distal Centralizer/Centering SleeveBiomet, Inc.K193546Distal CentralizersBiomet, Inc.K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker OrthopaedicsK001984PROGENY FORGED COCR CEMENTED FEMORAL COMPONENTStelkast CompanyK992234THE TAPER-FIT TOTAL HIP SYSTEMCorin USAK962002AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEMExactech, 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.

↑