FDA 510(k)

MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS

K-Number: K082792 · 2008-12-29

Decision Date2008-12-29

Product CodeJDI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2008-12-29 under 510(k) number K082792. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS?

MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS is a medical device that received FDA 510(k) clearance on 2008-12-29. The listed applicant is Medacta International S.A.. The 510(k) number is K082792.

When did MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS receive FDA 510(k) clearance?

MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS received FDA 510(k) clearance on 2008-12-29, under 510(k) number K082792.

Who is the listed applicant for MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS?

The FDA 510(k) record lists Medacta International S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS?

The FDA product code for MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS is JDI.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medacta International S.A. as applicant

K260173M-Vizion Femoral Revision System Extension K253630Mpact 3D Metal Foam K254202MectaLIF 3D Metal Anterior K253940M.U.S.T. Pedicle Screw System - Extension K253328GMK 3D Metal Tibial Tray Extension K250644MSS - Monobloc stem

View all 167 devices →

Related Devices (Code: JDI)

K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer Biomet K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics

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.