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510(k) K880826

Device
MICROLOC(TM) POROUS COATED UNICONDYLAR KNEE SYSTEM
Applicant
JOHNSON & JOHNSON PROFESSIONALS, INC.
510(k) number
K880826
Product code
KYK  
Decision
Substantially Equivalent (SESE)
Decision date
1988-03-14
Date received
1988-03-01
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
MARSHA J STONE
Address
325 Paramount Dr. Raynham MA US 02767 02767

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
K871118MODIFIED TOWNLEY UNICONDYLAR KNEEDepuy, Inc.1987-04-06
K851341SYNATOMIC VARIABLE FIT TIBIAL PLATEAUDepuy, Inc.1985-07-15

Legacy Summary#

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FDA Review#

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