FDA 510(k)

REDAPT Sleeved Monolithic Revision Stems

K-Number: K162303 · 2017-05-01

Decision Date2017-05-01

Product CodeMEH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

REDAPT Sleeved Monolithic Revision Stems is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2017-05-01 under 510(k) number K162303. 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 REDAPT Sleeved Monolithic Revision Stems?

REDAPT Sleeved Monolithic Revision Stems is a medical device that received FDA 510(k) clearance on 2017-05-01. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K162303.

When did REDAPT Sleeved Monolithic Revision Stems receive FDA 510(k) clearance?

REDAPT Sleeved Monolithic Revision Stems received FDA 510(k) clearance on 2017-05-01, under 510(k) number K162303.

Who is the listed applicant for REDAPT Sleeved Monolithic Revision Stems?

The FDA 510(k) record lists Smith & Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REDAPT Sleeved Monolithic Revision Stems?

The FDA product code for REDAPT Sleeved Monolithic Revision Stems 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.

NCT02440672JOURNEY™ II CR Total Knee SystemACTIVE_NOT_RECRUITING NCT03247023Long Term Follow-up of Integra® Cadence™ Total Ankle System in Primary Ankle Joint ReplacementTERMINATED NCT03985839Safety and Performance of MICRORAPTOR™ Suture Anchors in Shoulder and HipCOMPLETED NCT04325022Safety and Effectiveness Study of OR3O™ Dual Mobility System in THAACTIVE_NOT_RECRUITING NCT04849884To Evaluate the Performance of the CORI™ KNEE TENSIONER as an Accessory to the CORI™ Surgical System.COMPLETED NCT05444465Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness TearsRECRUITING

Other records listing Smith & Nephew, Inc. as applicant

K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)K254084AETOS Shoulder System - CONCELOC Glenoids PMA P000057Finger semi-constrained pyrolytic carbon uncemented prosthesis K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0 K252129AETOS Shoulder System Stemless Humeral Prosthesis K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)

View all 125 devices →

Related Devices (Code: MEH)

K261576Icona Hip StemCorin, Ltd.K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG K251166Mfinity Femoral SystemMedacta International S.A.K251052Trivicta® Hip StemOrtho Development Corp.K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation K243839Alteon® 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.