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510(k) K010212

Device
OFFSET TIBIAL TRAY
Applicant
BIOMET, INC.
510(k) number
K010212
Product code
MBV  
Decision
Substantially Equivalent (SESE)
Decision date
2001-02-14
Date received
2001-01-23
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
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CAROL LAUSTER
Address
Airport Industrial Park P.O. Box 587 Warsaw IN US 46581 46581

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MBV  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K884824TRICON-M TOTAL KNEE SYSTEMRichards Medical Co., Inc.1989-11-21
K873429FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEEProtek, Inc.1987-10-28
K853730FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REPProtek, Inc.1986-02-18
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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