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510(k) K010847

Device
K'FIX
Applicant
AVANTA ORTHOPAEDICS, INC.
510(k) number
K010847
Product code
NDL  
Decision
Substantially Equivalent (SESE)
Decision date
2001-06-19
Date received
2001-03-21
Regulation
888.3040
Classification name
Pin, Fixation, Smooth, Metallic
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LOUISE M FOCHT
Address
9369 Carroll Park Dr., Suite A San Diego CA US 92121 92121

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NDL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K010545TBWTri-Med, Inc.2001-06-06

Legacy Summary#

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FDA Review#

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