FDA.reportPublic FDA data

510(k) K760325

Device
SURGICAL INSTRUMENTS, ORTHOPEDIC
Applicant
DEPUY, INC.
510(k) number
K760325
Product code
HTX  
Decision
Substantially Equivalent (SESE)
Decision date
1976-08-03
Date received
1976-07-26
Regulation
888.4540
Classification name
Rongeur
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 HTX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K874954MANUAL RONGEURSolway, Inc.1987-12-30
K841620FRONT RADIUS CUTTERPlastafil, Inc.1984-09-20
K841621BACK RADIUS CUTTERPlastafil, Inc.1984-09-20
K780397ORTHOPEDIC FORCEPSOrthopedic Equipment Co., Inc.1978-03-22

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases