ClearanceBrief
Panels › Orthopedic › Product code LZO · Class 2

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Regulation 888.3353

9510(k)s in 12 months (535 all time)
0recalls in 12 months (177 all time)
168recalls that name a 510(k)
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Top companies in LZO

Company510(k)sRecalls
Zimmer GmbH3435
Stryker Howmedica Osteonics051
Medacta International380
Exactech, Inc.2115
Corin U.S.A. Limited275
Biomet, Inc.218
Howmedica Osteonics242
Smith & Nephew, Inc.242
Microport Orthopedics, Inc.138
Howmedica Corp.190
Decided510(k)Device and applicantCode
Aug 6, 2019K191781Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System
Zimmer GmbH, CH
LZO
Aug 6, 2019K190535BiMobile Dual Mobility System - E-Dur Inserts
Waldemar Link GmbH & Co. KG, DE
LZO
Jul 22, 2019K191374Revival Modular Hip Stem
Corin U.S.A. Limited
LZO
Jul 22, 2019K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)
Corin USA
LZO
Jul 18, 2019K183532Latitud Hip Replacement System
Meril Healthcare Pvt. , Ltd., IN
LZO
May 30, 2019K191145MasterLoc Extension
Medacta International S.A., CH
LZO
May 24, 2019K182321MobileLink Acetabular Cup System
Waldemar Link GmbH & Co. KG, DE
LZO
May 9, 2019K181491Delta Dual Mobility System
Lima Corporate S.P.A., IT
LZO
Apr 2, 2019K181171Zimmer Biomet Ceramic Heads
Zimmer, Inc.
LZO
Feb 22, 2019K183365Libertas Acetabular Hooded Liner
Maxx Orthopedics, Inc.
LZO
Feb 14, 2019K182705Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups
B-One Ortho, Corp.
LZO
Feb 8, 2019K183141LINK MP Monoblock Hip Prosthesis
Waldemar Link GmbH & Co. KG, DE
LZO
Jan 30, 2019K183136Zimmer Segmental System Proximal Femoral Component
Zimmer, Inc.
LZO
Dec 26, 2018K181761Zimmer Biomet Select Ceramic Heads
Zimmer, Inc.
LZO
Dec 11, 2018K181744BI-MENTUM dual mobility system
Serf, FR
LZO
Dec 7, 2018K182048Avenir Complete Hip System
Zimmer, Inc.
LZO
Nov 28, 2018K181693SMS Femoral Stem
Medacta International S.A., CH
LZO
Nov 8, 2018K182462Exactech Alteon Highly Polished Femoral Stem
Exactech, Inc.
LZO
Oct 22, 2018K181254Quadra P
Medacta International S.A., CH
LZO
Sep 21, 2018K173960DePuy Corail AMT Hip Prosthesis
Depuy France S.A.S., FR
LZO
Sep 20, 2018K173898MicroPort Orthopedics Total Hip Systems MR Labeling
Microport Orthopedics Inc. (Mpo)
LZO
Sep 14, 2018K181598Prime E-CLASS XLPE Liner
Microport Orthopedics, Inc.
LZO
Sep 7, 2018K181061Corin Optimized Positioning System (OPS) Femoral
Corin USA
LZO
Sep 4, 2018K181532Exactech Alteon Monobloc Revision Stem
Exactech, Inc.
LZO
Aug 30, 2018K173380b-ONE® Total Hip System
B-One Ortho, Corp.
LZO
Jul 20, 2018K180263EcoFit Vit E Acetabular System
Implantcast GmbH, DE
LZO
Jul 6, 2018K173776BIOLOX delta Option and Extra-long Heads
Microport Orthopedics, Inc.
LZO
May 9, 2018K180929Klassic HD® Hip System
Total Joint Orthopedics, Inc.
LZO
Apr 26, 2018K170339Summit Hip System
DePuy Orthopaedics, Inc.
LZO
Mar 28, 2018K172235CoreHip® System
Aesculap Implants Systems, LLC
LZO
Mar 14, 2018K173794AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared
Medacta International S.A., CH
LZO
Dec 21, 2017K172467OMNI ARC Anteverted Neck Hip Stem
Omnilife Science
LZO
Dec 7, 2017K173267MasterLoc Stem: Lateralized Plus
Medacta International S.A., CH
LZO
Nov 29, 2017K170690M-Vizion Femoral Revision System
Medacta International S.A., CH
LZO
Nov 8, 2017K170473C2 femoral stem
Lima Corporate S.P.A., IT
LZO
Oct 31, 2017K170359Trinity™ Dual Mobility System
Corin U.S.A. Limited
LZO
Oct 6, 2017K170089U-Motion II Acetabular System— Additional sizes
United Orthopedic Corporation, TW
LZO
Sep 25, 2017K163577Ecofit® Hip System
Implantcast GmbH, DE
LZO
Aug 28, 2017K171181PROCOTYL® PRIME E-CLASS™ XLPE Liner
Microport Orthopedics, Inc.
LZO
Aug 25, 2017K163441Locking Cage, Full XPE Cup
United Orthopedic Corporation, TW
LZO
Aug 17, 2017K171156OMNI Anseris Hip Stem
Omnilife Science
LZO
Aug 8, 2017K170845MiniMAX
Medacta International S.A., CH
LZO
Jun 20, 2017K162942Corin MetaFix Hip Stem
Corin U.S.A. Limited
LZO
Jun 2, 2017K163585Responsive Orthopedics Total Hip Arthroplasty System
Responsive Orthopedics, LLC
LZO
Mar 31, 2017K161635AMIStem-H Proximal Coating
Medacta International S.A., CH
LZO
Mar 16, 2017K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and
Waldemar Link GmbH & Co. KG, DE
LZO
Feb 10, 2017K161226Revision Femoral Stem
Lima Corporate S.P.A., IT
LZO
Nov 1, 2016K160895Initia Total Hip System & BIOCERAM AZUL(R) HEAD
Kyocera Medical Corporation, JP
LZO
Oct 26, 2016K161830Zimmer M/L Taper Hip Prosthesis
Zimmer, Inc.
LZO
Jul 8, 2016K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System
Zimmer GmbH, CH
LZO

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