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510(k) K021749

Device
EBI DYNAFIX VS OSTEOTOMY SYSTEM
Applicant
EBI, L.P.
510(k) number
K021749
Product code
NDF  
Decision
Substantially Equivalent (SESE)
Decision date
2002-08-12
Date received
2002-05-28
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
JON CAPARETTA
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
K010551EBI DYNAFIX VS OSTEOTOMY SYSTEMEbi, L.P.2001-05-17

Legacy Summary#

summary

FDA Review#

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