FDA.reportPublic FDA data

510(k) K051642

Device
FR.O.H. CALCANEUS REPAIR SYSTEM
Applicant
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH
510(k) number
K051642
Product code
NDF  
Decision
Substantially Equivalent (SESE)
Decision date
2005-08-22
Date received
2005-06-20
Regulation
888.3030
Classification name
Plate, Fixation, Bone, Non-spinal, Metallic
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
AL LIPPINCOTT
Address
3150 E. 200th. St. Prior Lake MN US 55372 55372

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NDF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K021749EBI DYNAFIX VS OSTEOTOMY SYSTEMEbi, L.P.2002-08-12
K010551EBI DYNAFIX VS OSTEOTOMY SYSTEMEbi, L.P.2001-05-17

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases