KWH

Product Code: KWH


Products Classified as KWH

4566Prosthesis, Toe, Constrained, PolymerToe Joint Polymer Constrained Prosthesis.

Total Product Life Cycle (TPLC) Devices

4566Prosthesis, Toe, Constrained, PolymerToe Joint Polymer Constrained Prosthesis.

FDA Consensus Standards

Prosthesis, Toe, Constrained, Polymer [37410]21 CFR §888.3720 🔎
Prosthesis, Toe, Constrained, Polymer [37411]21 CFR §888.3720 🔎

Pre-market Notifications for KWH

K191966NewPrim SystemBRM Extremities
K190136Fusion Silastic SystemFusion Orthopedics, LLC
K173491RTS Lesser MTP Implant SystemIn2Bones USA, LLC
K153609RTS Flexible 1 MPJ Implant W/GrommetsIn2BonesUSA, LLC
K102601ORTHOFLEX RODORTHO-PRO LLC
K023562MODIFICATION TO CLASSIC GREAT TOE IMPLANTNEXA ORTHOPEDICS, INC.
K023531LESSER METATARSAL PHALANGEAL JOINT IMPLANTNEXA ORTHOPEDICS, INC.
K023086CLASSIC GREAT TOE IMPLANTNEXA ORTHOPEDICS, INC.
K022887INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEMOSTEOMED CORP.
K994326ASCENT KNEE SYSTEMBIOMET MANUFACTURING, INC.
K981194FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANTNEXA ORTHOPEDICS, INC.
K946236PROFIX CONFORMING PLUS TIBIAL INSERTSMITH & NEPHEW RICHARDS, INC.
K943354SUTTER HAMMERTOE JOINT PROSTHESISSUTTER CORP.
K905795SGARLATO FLEXIBLE HINGE TOE IMPLANTSGARLATO LABORATORIES, INC.
K884739SGARLATO LESSER TOE IMPLANTSGARLATO LABORATORIES, INC.

Global Unique Device Identification Database

00817906024302Prosthesis, Toe, Constrained, Polymer
00817906024296Prosthesis, Toe, Constrained, Polymer
00817906024289Prosthesis, Toe, Constrained, Polymer
00817906020069Prosthesis, Toe, Constrained, Polymer
00817906020052Prosthesis, Toe, Constrained, Polymer
00817906020045Prosthesis, Toe, Constrained, Polymer
00817906020038Prosthesis, Toe, Constrained, Polymer
00817906020021Prosthesis, Toe, Constrained, Polymer
00817906020014Prosthesis, Toe, Constrained, Polymer
00817906020007Prosthesis, Toe, Constrained, Polymer
00885556416785PROSTHESIS, TOE, CONSTRAINED, POLYMER
00885556416730PROSTHESIS, TOE, CONSTRAINED, POLYMER
00885556416686PROSTHESIS, TOE, CONSTRAINED, POLYMER
00885556416631PROSTHESIS, TOE, CONSTRAINED, POLYMER
00885556416587PROSTHESIS, TOE, CONSTRAINED, POLYMER

Maude Adverse Events

SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.2019-11-14
ATTUNE MEDIAL ANAT PAT 32MMDEPUY IRELAND - 96166712019-11-06
LPS DISTAL FEM COMP XXSM RTDEPUY ORTHOPAEDICS INC US2019-10-11
RTS FLEXIBLE 1AT MPJ IMPLANTIN2BONES USA2019-09-06
SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.2019-09-03
FUTURA FGT SIZE 20 IMPLANTTORNIER INC2019-08-05
ATTUNE RP PS ARTIC SURF SZ8DEPUY IRELAND 96166712019-05-16
SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.2019-03-04
SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.2019-03-04
SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.2019-03-04
SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.2019-03-04
SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.2019-03-04
SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.2019-03-04
SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.2019-03-04
ATTUNE CONV FB PS TB TRL SZ7DEPUY IRELAND 96166712019-01-10
R3 CONST 52MMSMITH & NEPHEW, INC.2018-10-24
PRO CONF PL TB ISRT RT S4 12SMITH & NEPHEW ORTHOPAEDICS AG2018-08-29
SWANSON FLEX HINGE LATERAL TOE INSTRUMENT + IMPLANTWRIGHT MEDICAL TECHNOLOGY INC.2018-08-06
SWANSON FLEX HINGE LATERAL TOE INSTRUMENT + IMPLANTWRIGHT MEDICAL TECHNOLOGY INC.2018-08-06
PRO CONF PL TB ISRT RT S2 10SMITH & NEPHEW, INC.2018-06-30
SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.2018-04-23
CUSTOM RS FEMORAL AXLEZIMMER BIOMET, INC.2018-03-26
UNKNOWN SMART TOESTRYKER GMBH2018-02-09
NEXA FGT IMPLANT SIZE 20ASCENSION ORTHOPEDICS2017-06-08
FUTURA IMPLANTASCENSION ORTHOPEDICS2017-06-08
NEXA FGT IMPLANT SIZE 50ASCENSION ORTHOPEDICS2017-06-08
TOE IMPLANT-UNSPECIFIEDASCENSION ORTHOPEDICS2016-11-23
LESSER METATARSAL PHALANGEAL JOINT IMPLANTTORNIER INC.2016-06-29
SWANSON FLEXIBLE HINGE TOE WITH GROMMETSWRIGHT MEDICAL TECHNOLOGY, INC.2016-05-23
UNKNOWN EXTREMITYBIOMET ORTHOPEDICS2016-04-08
ATTUNE FB CR ARTIC SURF SZ7DEPUY ORTHOPAEDICS, INC.2016-01-07
FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT INSTRUMENTTORNIER INC.2016-01-04
FUTURA GREAT TOETORNIER INC.2015-12-04
UNKNOWN DEPUY CEMENT9610921 DEPUY CMW2015-11-25
PRIMUS FLEXIBLE GREAT TOE WITH GROMMETS IMPLANT (FGT)TORNIER, INC.2015-09-17
ASCEND HUMERAL STEM SIZE 4A; 78MM 127.52015-03-19
HUMERAL STEM MEDIUM STANDARD RIGHTTORNIER, INC.2015-03-16
LATITUDE ULNAR CAP MEDIUMTORNIER, INC.2015-03-16
PRIMUS FLEXIBLE GREAT TOE IMPLANT, SIZE 30TORNIER INC.2015-03-05
INTER-PHALANGEAL STERILE SURGICAL KITOSTEOMED2014-08-22
UNKUNKTORNIER INC.,2014-08-19
PRIMUS GREAT TOE IMPLANT WITH GROMMETS SIZE 20TORNIER INC.2014-08-19
GMK SPHERE FLEX TIBIAL INSERT SIZE 3 LEFT 10MMMEDACTA INTERNATIONAL SA2014-07-30
INTER-PHALANGEAL STERILE SURGICAL KITOSTEOMED2014-07-17
GAITSGARLATO MED LLC2014-02-26
PRIMUS FLEXIBLE GREAT TOE IMPLANTTORNIER INC2013-08-01
PRIMUS FUTURA GREAT TOW IMPLANT UNKTORNIER IN.2013-03-12
PRIMUS FUTURA GREAT TOE IMPLANT UNKTORNIER, INC.2013-03-12
GAIT IMPLANTSGARLATO LABS2013-02-06
CLASSIC GREAT TOE IMPLANT SIZE 50TORNIER INC2013-01-31

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