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510(k) K140576

Device
Y WIRE 2
Applicant
SAFEWIRE, LLC
510(k) number
K140576
Product code
HXI  
Decision
Substantially Equivalent (SESE)
Decision date
2014-05-20
Date received
2014-03-06
Regulation
888.4540
Classification name
Passer, Wire, Orthopedic
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
STEPHEN W INGLESE
Address
520 Butternut Dr., #8 Pmb#256 Holland MI US 49424 49424

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HXI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K863146BOWEN SUTURE PASSERBowen & Company, Inc.1986-09-05
K863148BOWEN KNOT PASSERBowen & Company, Inc.1986-09-05

Legacy Summary#

summary

FDA Review#

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