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510(k) K180092

Device
Intellitorq
Applicant
Gauthier Biomedical, Inc.
510(k) number
K180092
Product code
HXC  
Decision
Substantially Equivalent (SESE)
Decision date
2018-03-08
Date received
2018-01-12
Regulation
888.4540
Classification name
Wrench
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Austin Braganza
Address
2221 Washington St. Grafton WI US 53024 53024

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HXC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K874358COMBINATION WRENCHESMed-Tool, Inc.1987-11-23
K874359ADJUSTABLE WRENCHESMed-Tool, Inc.1987-11-23
K870053TORQUEDRIVER WRENCHJerome Medical1987-03-11
K813067SPINAL WRENCHTwin City Surgical, Inc.1981-11-24
K791073WRENCHTruth, Inc.1979-06-20

Legacy Summary#

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FDA Review#

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