Kevin Smith

FDA Filings

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

FDA Registration(s)

• Registration Number: 3008337808
• FEI Number: 3008337808
• Name: Kevin Smith
• Owner & Operator: Tornier Inc.
• Contact Address: 10801 Nesbitt Avenue South --; Bloomington MN 55437 US
• Official Correspondent:
  • Kris Tucker
  • x-952-9217138-x
• US Agent:
  • Kevin Smith
  • Tornier Inc
  • 952 9217121
  • 952 4267601
  • KSmith@tornier.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 10801 Nesbitt Ave S ; Bloomington, MN 55437 US
• Establishment Type:
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K190521 | KWT Kevin Smith [Tornier Inc.]	Aequalis? Ascend? Flex Shoulder System	2019-11-19
PMN K190521 | KWS Kevin Smith [Tornier Inc.]	Aequalis? Ascend? Flex Shoulder System	2019-11-19
PMN K190521 | HSD Kevin Smith [Tornier Inc.]	Aequalis? Ascend? Flex Shoulder System	2019-11-19
PMN K182461 | JDC Kevin Smith [Tornier Inc.]	LATITUDE EV	2018-12-27
PMN K182461 | JDB Kevin Smith [Tornier Inc.]	LATITUDE EV	2018-12-27
PMN K161742 | PHX Kevin Smith [Tornier Inc.]	AEQUALIS PerFORM+ Reversed	2016-11-16
PMN K161742 | PHX Kevin Smith [Tornier Inc.]	AEQUALIS PerFORM Reversed	2016-11-16
PMN K161742 | KWS Kevin Smith [Tornier Inc.]	AEQUALIS PerFORM+ Reversed	2016-11-16
PMN K161742 | KWS Kevin Smith [Tornier Inc.]	AEQUALIS PerFORM Reversed	2016-11-16
PMN K160975 | KWS Kevin Smith [Tornier Inc.]	Aequalis PerFORM+	2016-06-13
PMN K151293 | PHX Kevin Smith [Tornier Inc.]	Aequalis Reversed Shoulder Prosthesis	2015-10-12
PMN K151293 | PHX Kevin Smith [Tornier Inc.]	Aequalis Ascend Flex Shoulder System	2015-10-12
PMN K151293 | KWT Kevin Smith [Tornier Inc.]	Aequalis Reversed Shoulder Prosthesis	2015-10-12
PMN K151293 | KWT Kevin Smith [Tornier Inc.]	Aequalis Ascend Flex Shoulder System	2015-10-12
PMN K151293 | KWS Kevin Smith [Tornier Inc.]	Aequalis Reversed Shoulder Prosthesis	2015-10-12
PMN K151293 | KWS Kevin Smith [Tornier Inc.]	Aequalis Ascend Flex Shoulder System	2015-10-12
PMN K151293 | HSD Kevin Smith [Tornier Inc.]	Aequalis Reversed Shoulder Prosthesis	2015-10-12
PMN K151293 | HSD Kevin Smith [Tornier Inc.]	Aequalis Ascend Flex Shoulder System	2015-10-12
PMN K143552 | PKC Kevin Smith [Tornier Inc.]	Simpliciti Shoulder System	2015-03-09
PMN K131231 | PHX Kevin Smith [Tornier Inc.]	Aequalis Shoulder Fracture System	2015-01-14
PMN K131231 | PHX Kevin Smith [Tornier Inc.]	Aequalis Reversed Shoulder Prosthesis	2015-01-14
PMN K131231 | PHX Kevin Smith [Tornier Inc.]	Aequalis Reversed Fracture Shoulder Prosthesis	2015-01-14
PMN K131231 | KWS Kevin Smith [Tornier Inc.]	Aequalis Shoulder Fracture System	2015-01-14
PMN K131231 | KWS Kevin Smith [Tornier Inc.]	Aequalis Reversed Shoulder Prosthesis	2015-01-14
PMN K131231 | KWS Kevin Smith [Tornier Inc.]	Aequalis Reversed Fracture Shoulder Prosthesis	2015-01-14
PMN K131231 | HSD Kevin Smith [Tornier Inc.]	Aequalis Shoulder Fracture System	2015-01-14
PMN K131231 | HSD Kevin Smith [Tornier Inc.]	Aequalis Reversed Shoulder Prosthesis	2015-01-14
PMN K131231 | HSD Kevin Smith [Tornier Inc.]	Aequalis Reversed Fracture Shoulder Prosthesis	2015-01-14
HXX Kevin Smith [Tornier Inc.]	Screwdriver	2014-11-09
HXX Kevin Smith [Tornier Inc.]	Mini Variable	2014-11-09
HXX Kevin Smith [Tornier Inc.]	Mini MaxTorque	2014-11-09
HXX Kevin Smith [Tornier Inc.]	Mini MaxLock	2014-11-09
HXX Kevin Smith [Tornier Inc.]	MaxTorque	2014-11-09
HXX Kevin Smith [Tornier Inc.]	MaxLock Extreme	2014-11-09
HXX Kevin Smith [Tornier Inc.]	Intraosseous Fixation System	2014-11-09
HXX Kevin Smith [Tornier Inc.]	HexStar	2014-11-09
HXX Kevin Smith [Tornier Inc.]	DRLock Extreme	2014-11-09
HXX Kevin Smith [Tornier Inc.]	CalcLock Extreme	2014-11-09
PMN K140478 | KWS Kevin Smith [Tornier Inc.]	Aequalis Reversed Titanium Glenoid Sphere	2014-09-05
PMN K140082 | PHX Kevin Smith [Tornier Inc.]	Aequalis Ascend Flex Titanium Head	2014-09-05
PMN K140082 | KWT Kevin Smith [Tornier Inc.]	Aequalis Ascend Flex Titanium Head	2014-09-05
PMN K140082 | KWS Kevin Smith [Tornier Inc.]	Aequalis Ascend Flex Titanium Head	2014-09-05
PMN K140082 | HSD Kevin Smith [Tornier Inc.]	Aequalis Ascend Flex Titanium Head	2014-09-05
PMN K132285 | PHX Kevin Smith [Tornier Inc.]	Aequalis Reversed II - Threaded Post Baseplate	2013-12-10
PMN K132285 | KWS Kevin Smith [Tornier Inc.]	Aequalis Reversed II - Threaded Post Baseplate	2013-12-10
PMN K122698 | KWS Kevin Smith [Tornier Inc.]	Aequalis Ascend FLEX Shoulder System	2013-01-10
PMN K113413 | KWT Kevin Smith [Tornier Inc.]	ASCEND SHOULDER SYSTEM	2012-04-26
PMN K113413 | KWS Kevin Smith [Tornier Inc.]	ASCEND SHOULDER SYSTEM	2012-04-26
PMN K113413 | HSD Kevin Smith [Tornier Inc.]	ASCEND SHOULDER SYSTEM	2012-04-26
PMN K120794 | KWT Kevin Smith [Tornier Inc.]	SHOULDER - ASCEND FLEX PTC STEM	2012-04-18
PMN K120794 | KWT Kevin Smith [Tornier Inc.]	SHOULDER - ASCEND FLEX CEMENTED STEM	2012-04-18
PMN K120794 | KWT Kevin Smith [Tornier Inc.]	ASCEND? Monolithic Shoulder System (PTC stems)	2012-04-18
PMN K120794 | KWS Kevin Smith [Tornier Inc.]	SHOULDER - ASCEND FLEX PTC STEM	2012-04-18
PMN K120794 | KWS Kevin Smith [Tornier Inc.]	SHOULDER - ASCEND FLEX CEMENTED STEM	2012-04-18
PMN K120794 | KWS Kevin Smith [Tornier Inc.]	ASCEND? Monolithic Shoulder System (PTC stems)	2012-04-18
PMN K120794 | HSD Kevin Smith [Tornier Inc.]	SHOULDER - ASCEND FLEX PTC STEM	2012-04-18
PMN K120794 | HSD Kevin Smith [Tornier Inc.]	SHOULDER - ASCEND FLEX CEMENTED STEM	2012-04-18
PMN K120794 | HSD Kevin Smith [Tornier Inc.]	ASCEND? Monolithic Shoulder System (PTC stems)	2012-04-18
PMN K111902 | KWS Kevin Smith [Tornier Inc.]	Aequalis Shoulder System	2011-11-21
HTW Kevin Smith [Tornier Inc.]	Tornier Drill bits (all)	2010-12-20
PMN K082120 | PHX Kevin Smith [Tornier Inc.]	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED	2009-03-18
PMN K082120 | KWS Kevin Smith [Tornier Inc.]	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED	2009-03-18
PMN K081059 | PHX Kevin Smith [Tornier Inc.]	AEQUALIS REVERSED SHOULDER PROSTHESIS	2008-10-30
PMN K081059 | KWS Kevin Smith [Tornier Inc.]	AEQUALIS REVERSED SHOULDER PROSTHESIS	2008-10-30
PMN K994393 | KWS Kevin Smith [Tornier Inc.]	Aequalis	2007-12-10
PMN K994392 | KWS Kevin Smith [Tornier Inc.]	Aequalis Shoulder System - glenoid	2007-12-10
PMN K952928 | KWS Kevin Smith [Tornier Inc.]	Aequalis Shoulder system	2007-12-10
PMN K952928 | HSD Kevin Smith [Tornier Inc.]	Aequalis Shoulder system	2007-12-10
PMN K063081 | HSD Kevin Smith [Tornier Inc.]	AEQUALIS SHOULDER SYSTEM	2007-12-10
PMN K061824 | LZN Kevin Smith [Tornier Inc.]	Cement Restrictor	2007-12-10
PMN K061439 | PHX Kevin Smith [Tornier Inc.]	AEQUALIS REVERSED PROSTHESIS	2007-12-10
PMN K061439 | KWS Kevin Smith [Tornier Inc.]	AEQUALIS REVERSED PROSTHESIS	2007-12-10
PMN K060988 | MBF Kevin Smith [Tornier Inc.]	Total and Hemi Shoulder System	2007-12-10
PMN K060988 | MBF Kevin Smith [Tornier Inc.]	AFFINITI? SHOULDER SYSTEM	2007-12-10
PMN K060988 | KWS Kevin Smith [Tornier Inc.]	Total and Hemi Shoulder System	2007-12-10
PMN K060988 | KWS Kevin Smith [Tornier Inc.]	AFFINITI? SHOULDER SYSTEM	2007-12-10
PMN K060988 | HSD Kevin Smith [Tornier Inc.]	Total and Hemi Shoulder System	2007-12-10
PMN K060988 | HSD Kevin Smith [Tornier Inc.]	AFFINITI? SHOULDER SYSTEM	2007-12-10
PMN K060209 | KWS Kevin Smith [Tornier Inc.]	Aequalis Shoulder System	2007-12-10
PMN K060209 | KWS Kevin Smith [Tornier Inc.]	Aequalis Shoulder Fracture System	2007-12-10
PMN K041873 | PHX Kevin Smith [Tornier Inc.]	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED	2007-12-10
PMN K041873 | KWS Kevin Smith [Tornier Inc.]	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED	2007-12-10
PMN K041339 | KWS Kevin Smith [Tornier Inc.]	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED	2007-12-10
PMN K030941 | PHX Kevin Smith [Tornier Inc.]	AEQUALIS REVERSED SHOULDER PROSTHESIS	2007-12-10
PMN K071147 | KWT Kevin Smith [Tornier Inc.]	ASCEND? Monolithic Shoulder System	2007-11-30
PMN K071147 | HSD Kevin Smith [Tornier Inc.]	ASCEND? Monolithic Shoulder System	2007-11-30

Similar & Related FDA Registered Companies

• TORNIER INC.
• TORNIER

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092990432	Yantian,China (Mainland) -> Los Angeles, California	HOME DECOR ATRICLE	1 PCS
2020092981308	Yantian,China (Mainland) -> Los Angeles, California	HOME DECOR ATRICLE	1 PCS
2020092991134	Yantian,China (Mainland) -> Los Angeles, California	HOME DECOR ATRICLE	1 PCS
2020091170104	Yantian,China (Mainland) -> Long Beach, California	TABLE DECORATION	1 PCS
2020090271443	Yantian,China (Mainland) -> Los Angeles, California	TABLE DECORATION	1 PCS
2020081049634	Yantian,China (Mainland) -> Los Angeles, California	CHILDREN TOY ACCESSORY	1 PCS
2020060328518	Yantian,China (Mainland) -> Oakland, California	CHEST EXPANDER NCYD00002 S01	1 PCS
2020060150582	Yantian,China (Mainland) -> Oakland, California	SHAVER	1 PCS