FDA.reportPublic FDA data

510(k) K820957

Device
Suface Replacement Elbow
Applicant
HOWMEDICA CORP.
510(k) number
K820957
Product code
JDB
Decision
Substantially Equivalent (SESE)
Decision date
1982-07-02
Date received
1982-04-06
Regulation
888.3160
Classification name
Prosthesis, Elbow, Semi-Constrained, Cemented
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 JDB#

510(k), Device, Applicant table
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K182461LATITUDE EV Total Elbow ArthroplastyTornier, Inc.2018-12-27
K171010Latitude EV Total Elbow ArthroplastyTornier, Inc.2017-08-31
K102180RHEAD RADIAL HEAD EXTENDED STEMSSmall Bone Innovations, Inc.2010-12-20
K100562LATITUDE ELBOW PROSTHESISTornier, Inc.2010-06-29
K070787LATITUDE ELBOW PROTHESISTornier2007-08-24
K070236SBI LATERAL RADIO CAPITELLUMSmall Bone Innovations, Inc.2007-02-21
K060438RHSTornier2006-04-18
K060038SBI RADIO-CAPITELLAR IMPLANTSmall Bone Innovations, Inc.2006-03-30
K050848TORNIER ELBOW PROSTHESISTornier2005-07-14
K031218MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESISTornier2003-05-16
K011567TORNIER TOTAL ELBOW PROSTHESISTornier2001-06-19
K983141CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESISJohnson & Johnson Professionals, Inc.1998-11-06
K972691ABC TOTAL ELBOW PROTHESISBiomet, Inc.1997-10-15