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)

EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP

K-Number: K994146 · 2000-12-11

ApplicantPlus Orthopedics
Decision Date2000-12-11
Product CodeLWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP is the device name listed in this FDA 510(k) record. The listed applicant is Plus Orthopedics. It received FDA 510(k) clearance on 2000-12-11 under 510(k) number K994146. The device is classified under product code LWJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP?

EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP is a medical device that received FDA 510(k) clearance on 2000-12-11. The listed applicant is Plus Orthopedics. The 510(k) number is K994146.

When did EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP receive FDA 510(k) clearance?

EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP received FDA 510(k) clearance on 2000-12-11, under 510(k) number K994146.

Who is the listed applicant for EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP?

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

What is the FDA product code for EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP?

The FDA product code for EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP is LWJ.

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 Plus Orthopedics 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.

K032126PROMOS SHOULDERK033763MODIFICATION TO SLIM GLIDING NAIL SYSTEMK032709MODULAR PLUS HIP STEMK032548IP-XS COMPRESSION NAIL SYSTEMK032215VKS/TC-PLUS REVISION KNEEK032052UC-PLUS SOLUTION UNICONDYLAR KNEE

View all 38 devices →

Related Devices (Code: LWJ)

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.

K120595UNISYN PLUS HIP STEMConsensus Orthopedics, Inc.K103518TRINITY ACETABULAR SYSTEMCorin USAK090764NOVATION CFS PRESS-FIT AND CEMENTED STEMSExactech, Inc.K082146METHA SHORT STEM HIP SYSTEM XL FEMORAL HEADAesculap Implant Systems, Inc.K07006136MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERTHayes Medical, Inc.K062978U2 HIP STEM, TI PLASMA SPRAYUnited Orthopedic 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.

↑