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510(k) K851341

Device
SYNATOMIC VARIABLE FIT TIBIAL PLATEAU
Applicant
DEPUY, INC.
510(k) number
K851341
Product code
KYK  
Decision
Substantially Equivalent (SESE)
Decision date
1985-07-15
Date received
1985-04-03
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
JUDITH DERMODY
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
K871118MODIFIED TOWNLEY UNICONDYLAR KNEEDepuy, Inc.1987-04-06

Legacy Summary#

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FDA Review#

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