FDA.reportPublic FDA data

510(k) K010551

Device
EBI DYNAFIX VS OSTEOTOMY SYSTEM
Applicant
EBI, L.P.
510(k) number
K010551
Product code
NDF  
Decision
Substantially Equivalent (SESE)
Decision date
2001-05-17
Date received
2001-02-26
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
PATRICIA FLOOD
Address
399 Jefferson Rd. Parsippany NJ US 07054 07054

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
K051642FR.O.H. CALCANEUS REPAIR SYSTEMI.T.S. Implantat-Technologie-Systeme GmbH2005-08-22
K021749EBI DYNAFIX VS OSTEOTOMY SYSTEMEbi, L.P.2002-08-12

Legacy Summary#

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

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