FDA.reportPublic FDA data

510(k) K823405

Device
Zimmer Great Toe
Applicant
ZIMMER, INC.
510(k) number
K823405
Product code
KWH
Decision
Substantially Equivalent (SESE)
Decision date
1983-01-24
Date received
1982-11-15
Regulation
888.3720
Classification name
Prosthesis, Toe, Constrained, Polymer
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KWH#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K191966NewPrim SystemBrm Extremities2020-02-13
K190136Fusion Silastic SystemFusion Orthopedics, LLC2019-10-21
K173491RTS Lesser MTP Implant SystemIn2bones USA, LLC2018-02-23
K153609RTS Flexible 1 MPJ Implant w/GrommetsIn2bones USA, LLC2016-09-08
K102601ORTHOFLEX RODOrtho-Pro, LLC2011-01-14
K023531LESSER METATARSAL PHALANGEAL JOINT IMPLANTNexa Orthopedics, Inc.2003-01-17
K022887INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEMOsteomed Corp.2002-11-26
K022886METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEMOsteomed Corp.2002-11-25
K023562MODIFICATION TO CLASSIC GREAT TOE IMPLANTNexa Orthopedics, Inc.2002-11-13
K023086CLASSIC GREAT TOE IMPLANTNexa Orthopedics, Inc.2002-10-04
K994326ASCENT KNEE SYSTEMBiomet Manufacturing, Inc.2000-01-07
K981194FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANTNexa Orthopedics, Inc.1998-06-30
K946236PROFIX CONFORMING PLUS TIBIAL INSERTSmith & Nephew Richards, Inc.1995-07-06
K943354SUTTER HAMMERTOE JOINT PROSTHESISSutter Corp.1995-06-12
K905795SGARLATO FLEXIBLE HINGE TOE IMPLANTSgarlato Laboratories, Inc.1991-05-29