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510(k) K813067

Device
SPINAL WRENCH
Applicant
TWIN CITY SURGICAL, INC.
510(k) number
K813067
Product code
HXC  
Decision
Substantially Equivalent (SESE)
Decision date
1981-11-24
Date received
1981-10-30
Regulation
888.4540
Classification name
Wrench
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
K180092IntellitorqGauthier Biomedical, Inc.2018-03-08
K874358COMBINATION WRENCHESMed-Tool, Inc.1987-11-23
K874359ADJUSTABLE WRENCHESMed-Tool, Inc.1987-11-23
K870053TORQUEDRIVER WRENCHJerome Medical1987-03-11
K791073WRENCHTruth, Inc.1979-06-20

Legacy Summary#

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FDA Review#

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