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510(k) K853730

Device
FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP
Applicant
PROTEK, INC.
510(k) number
K853730
Product code
MBV  
Decision
Substantially Equivalent (SESE)
Decision date
1986-02-18
Date received
1985-09-06
Regulation
888.3560
Classification name
Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
KENNETH EPLING
Address
2601 Fortune Cir. E. Suite 105b 2601 Fortune Cir. E. Suite 105b Indianapolis IN US 46241 46241

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MBV  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K010212OFFSET TIBIAL TRAYBiomet, Inc.2001-02-14
K884824TRICON-M TOTAL KNEE SYSTEMRichards Medical Co., Inc.1989-11-21
K873429FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEEProtek, Inc.1987-10-28
K833200TRICON M TOTAL KNEE SYSTEMRichards Medical Co., Inc.1983-11-29
K831441POROCOAT FREEMAN/SAMUELSON TOTAL KNEEDepuy, Inc.1983-09-01
K832302MARK I TOTAL KNEE SYS. ARTHROPLASTYAdvanced Biosearch Assn.1983-08-16
K830726MARK I & II TOTAL KNEE REPLACE. SYSAdvanced Biosearch Assn.1983-06-22
K823837RMC TOTAL KNEE SYSTEMRichard'S Medical Equip., Inc.1983-03-29
K830408FREEMAN/SAMUELSON TOTAL KNEEDepuy, Inc.1983-02-24
K822583TOTAL KNEE SYSTEMRichard'S Medical Equip., Inc.1982-10-04
K802921ICLH TIBIAL PLATEAUDepuy, Inc.1981-01-08
K780904KNEE, TOTAL, FEMORAL & TIBIALDepuy, Inc.1978-06-22
K780284TIBIAL PLATEUDepuy, Inc.1978-03-15

Legacy Summary#

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FDA Review#

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