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510(k) K853259

Device
MALLORY/HEAD TOTAL HIP SYSTEM
Applicant
BIOMET, INC.
510(k) number
K853259
Product code
KMC  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1985-11-01
Date received
1985-08-02
Regulation
888.3340
Classification name
Prosthesis, Hip, Semi-constrained, Composite/metal
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JUDITH DERMUDY
Address
P.O. Box 587 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 KMC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K936044ENHANCED MODULAR AUSTIN MOORE HIPZimmer, Inc.1994-04-26
K853524APR REVISION HIP PROSTHESIS, FEMORAL COMPONENTIntermedics Orthopedics1985-11-22

Legacy Summary#

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FDA Review#

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