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510(k) K800800

Device
PATELLAR COMPONENT FOR LUBINUS PATELLAR
Applicant
WALDEMAR LINK GMBH & CO. KG
510(k) number
K800800
Product code
HTG  
Decision
Substantially Equivalent (SESE)
Decision date
1980-04-21
Date received
1980-04-10
Regulation
888.3580
Classification name
Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HTG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K771708WORRELL PATELLADepuy, Inc.1977-10-06

Legacy Summary#

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FDA Review#

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