FDA 510(k)

Smith & Nephew, Inc. REDAPT Augments

K-Number: K171073 · 2017-11-21

Decision Date2017-11-21

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Smith & Nephew, Inc. REDAPT Augments 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 2017-11-21 under 510(k) number K171073. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Smith & Nephew, Inc. REDAPT Augments?

Smith & Nephew, Inc. REDAPT Augments is a medical device that received FDA 510(k) clearance on 2017-11-21. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K171073.

When did Smith & Nephew, Inc. REDAPT Augments receive FDA 510(k) clearance?

Smith & Nephew, Inc. REDAPT Augments received FDA 510(k) clearance on 2017-11-21, under 510(k) number K171073.

Who is the listed applicant for Smith & Nephew, Inc. REDAPT Augments?

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 Smith & Nephew, Inc. REDAPT Augments?

The FDA product code for Smith & Nephew, Inc. REDAPT Augments is LPH.

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.

NCT03720782Safety and Performance Study of the Legion Porous System in Total Knee ArthroplastyACTIVE_NOT_RECRUITING NCT05107414Journey 2 Multi Center Kinematic StudyCOMPLETED NCT07698717Prospective Catalystem CT-RSANOT_YET_RECRUITING 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

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: LPH)

K254043TRIVANCE™ Hip StemGlobus Medical, Inc.K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC K251270Taperloc® Complete Hip StemBiomet, Inc.K252623G7® Revision Acetabular SystemZimmer, Inc.K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.

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.