510(k) K871118

Device
Modified Townley Unicondylar Knee
Applicant
DEPUY, INC.
510(k) number
K871118
Product code
KYK
Decision
Substantially Equivalent for Some Indications (SN)
Decision date
1987-04-06
Date received
1987-03-19
Regulation
888.3500
Classification name
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
STEVE WENTWORTH
Address
P.O. Box 988 Warsaw IN US 46581 46581

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KYK#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K880826MICROLOC(TM) POROUS COATED UNICONDYLAR KNEE SYSTEMJohnson & Johnson Professionals, Inc.1988-03-14
K851341SYNATOMIC VARIABLE FIT TIBIAL PLATEAUDepuy, Inc.1985-07-15