United Surgical Inc

FDA Filings

This page includes the latest FDA filings for United Surgical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

United Surgical Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number2087423
FEI Number3003707831
NameUNITED SURGICAL INC
Owner & OperatorUNITED SURGICAL INC dba UNITED ORTHO
Contact Address2235 Pennsylvania St --
Fort Wayne IN 46803 US
Official Correspondent
  • Andrew M Opliger
  • x-260-4225827-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address2235 Pennsylvania St
Fort Wayne, IN 46803 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
UNITED SURGICAL INC [UNITED SURGICAL INC dba UNITED ORTHO]
Walking Boot2014-06-10
UNITED SURGICAL INC [UNITED SURGICAL INC dba UNITED ORTHO]
FKB ACL Knee Brace2014-02-07

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092232620Colombo Harbor,Sri Lanka -> Norfolk, VirginiaMEDICAL DEVICE81 PCS
2020092249026Colombo Harbor,Sri Lanka -> Norfolk, VirginiaMEDICAL DEVICE875 CTN
2020092232614Colombo Harbor,Sri Lanka -> Norfolk, VirginiaMEDICAL DEVICE4 PCS
2020092232615Colombo Harbor,Sri Lanka -> Norfolk, VirginiaMEDICAL DEVICE128 PCS
2020092232616Colombo Harbor,Sri Lanka -> Norfolk, VirginiaMEDICAL DEVICE26 PCS
2020092232617Colombo Harbor,Sri Lanka -> Norfolk, VirginiaMEDICAL DEVICE216 PCS
2020092232619Colombo Harbor,Sri Lanka -> Norfolk, VirginiaMEDICAL DEVICE41 PCS
2020091415907Singapore,Singapore -> Oakland, CaliforniaLEG WALKER WITH LINER, ANKLE STABIL IZER1594 CTN

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