Pivot I N T

FDA Filings

This page includes the latest FDA filings for Pivot I N T. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Pivot I N T holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• Lynette Howard

FDA Registration(s)

• Registration Number: 1000655211
• FEI Number: 1000655211
• Name: Lynette Howard
• Owner & Operator: Pivot International
• Contact Address: Pivot International 11030 Strang Line Road; Lenexa KS 66215 US
• US Agent:
  • Lynette Howard
  • Lyle Howard Corporation
  • 908 7884580
  • 352 3838338
  • lylehoward@aol.com
• Importing Logistics Registration:
  • Importer: Pivot International
  • Address: 10916 Strang Line Rd. ; Lenexa, KS 66215 UNITED STATES
  • Importer Type: Initial Importer
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 106 E 5th Ave ; Mount Dora, FL 32757 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 1000655158
• FEI Number: 1000655158
• Name: Pivot International
• Owner & Operator: Pivot International Inc
• Contact Address: 11030 Strang Line Rd. ; Lenexa KS 66215 US
• Official Correspondent:
  • Mark Dohnalek
  • x-913-3126911-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 11030 Strang Line Rd ; Lenexa, KS 66215 US
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

• Registration Number: 3012118269
• FEI Number: 3012118269
• Name: PIVOT INTERNATIONAL
• Owner & Operator: Pivot International
• Contact Address: 59 Hermosa Ave ; Millbrae CA 94030 US
• Official Correspondent:
  • Daniel Lee
  • 1-650-2597623-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 59 Hermosa Ave ; Millbrae, CA 94030 US

FDA Filings

Device Company	Device	Date
FWZ Pivot International [Pivot International Inc]	WalterLorenz Surgical Assist Arm	2018-07-19
FWZ Lynette Howard [Pivot International]	WalterLorenz Surgical Assist Arm	2018-07-19
KMI Pivot International [Pivot International Inc]	SURE Movement Monitor	2018-01-09
FLG Lynette Howard [Pivot International]	EndoSafe EndoBath	2013-01-15
HWE Lynette Howard [Pivot International]	iSIS Console	2011-12-08
HWE Lynette Howard [Pivot International]	MicroAire Console	2011-12-08
GEY Lynette Howard [Pivot International]	IQ Intelligent System	2010-05-13
GEY Lynette Howard [Pivot International]	Biomet Drill Driver	2010-05-13
FTT Lynette Howard [Pivot International]	Envisionier Endogo Camera	2007-09-14
FTT Lynette Howard [Pivot International]	ENDOSCOPIC SURGICAL CAMERA	2007-09-14

Similar & Related FDA Registered Companies

• Pivot Internatonal
• Pivot International Trading Company

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2018090538177	Singapore,Singapore -> Los Angeles, California	SUPERSLYDE ORIGINALS	2 PKG