Sintea Factory S R L

FDA Filings

This page includes the latest FDA filings for Sintea Factory S R L. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3003475199
• FEI Number: 3003475199
• Name: SINTEA FACTORY S.r.l.
• Owner & Operator: SINTEA FACTORY s.r.l.
• Contact Address: VIA E. FERMI 44 --; ASSAGO IT-MI Milano 20090 IT
• Official Correspondent:
  • GUIDO - ZORZOLI
  • 39-02-457902431-x
• US Agent:
  • N/A
  • N/A
  • 0
  • N/A
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: VIA ENRICO FERMI 44 ; ASSAGO Milano, 20090 IT
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K140787 | MNI SINTEA FACTORY S.r.l.	3Lock	2014-12-12
PMN K140787 | MNH SINTEA FACTORY S.r.l.	3Lock	2014-12-12
PMN K140787 | KWP SINTEA FACTORY S.r.l.	3Lock	2014-12-12
PMN K132907 | MAX SINTEA FACTORY S.r.l.	TLIF LITE	2014-12-12
PMN K132907 | MAX SINTEA FACTORY S.r.l.	PLIF LITE	2014-12-12
PMN K130402 | NDN SINTEA FACTORY S.r.l.	Sintea Plustek	2013-11-11
PMN K130402 | HXG SINTEA FACTORY S.r.l.	Sintea Plustek	2013-11-11
PMN K112861 | KWQ SINTEA FACTORY S.r.l.	Anterior Cervical Plate System	2012-12-17
PMN K112611 | MNI SINTEA FACTORY S.r.l.	PLS MULTI-AXIAL SCREWS	2012-12-17
PMN K112611 | MNH SINTEA FACTORY S.r.l.	PLS MULTI-AXIAL SCREWS	2012-12-17
PMN K112611 | KWP SINTEA FACTORY S.r.l.	PLS MULTI-AXIAL SCREWS	2012-12-17
PMN K101886 | MQP SINTEA FACTORY S.r.l.	DSC/ALF Spinal System	2012-12-17
PMN K101886 | KWQ SINTEA FACTORY S.r.l.	DSC/ALF Spinal System	2012-12-17
PMN K082679 | JEC SINTEA FACTORY S.r.l.	LAKI	2009-12-28
PMN K081631 | MNI SINTEA FACTORY S.r.l.	SINTEA BIOTECH PLS MULTI-AXIAL SCREWS	2009-12-28
PMN K081631 | MNH SINTEA FACTORY S.r.l.	SINTEA BIOTECH PLS MULTI-AXIAL SCREWS	2009-12-28
PMN K081631 | KWP SINTEA FACTORY S.r.l.	SINTEA BIOTECH PLS MULTI-AXIAL SCREWS	2009-12-28
PMN K072198 | OAR SINTEA FACTORY S.r.l.	Spider	2009-12-28
PMN K072198 | HXG SINTEA FACTORY S.r.l.	Spider	2009-12-28
PMN K072198 | HRX SINTEA FACTORY S.r.l.	Spider	2009-12-28
PMN K070181 | MQP SINTEA FACTORY S.r.l.	SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX	2007-10-15
PMN K070181 | MQP SINTEA FACTORY S.r.l.	DSC/ALF Spinal System	2007-10-15
PMN K070181 | KWQ SINTEA FACTORY S.r.l.	SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX	2007-10-15
PMN K070181 | KWQ SINTEA FACTORY S.r.l.	DSC/ALF Spinal System	2007-10-15
PMN K060513 | MNI SINTEA FACTORY S.r.l.	PLS Sunflower Multiaxial Screw	2007-10-15
PMN K060513 | MNH SINTEA FACTORY S.r.l.	PLS Sunflower Multiaxial Screw	2007-10-15
PMN K060513 | KWP SINTEA FACTORY S.r.l.	PLS Sunflower Multiaxial Screw	2007-10-15
PMN K041989 | KWQ SINTEA FACTORY S.r.l.	ACP Spinal System	2007-10-15
PMN K020085 | MNI SINTEA FACTORY S.r.l.	PLS System	2007-10-15
PMN K020085 | MNH SINTEA FACTORY S.r.l.	PLS System	2007-10-15
PMN K020085 | KWP SINTEA FACTORY S.r.l.	PLS System	2007-10-15
PMN K031154 | JDW SINTEA FACTORY S.r.l.	SINTEA BIOTECH SCHANZ SCREW	2005-12-07
PMN K031154 | JDW SINTEA FACTORY S.r.l.	MODEL TFX.SS.XX.X	2005-12-07
PMN K022065 | JEC SINTEA FACTORY S.r.l.	SINTEA BIOTECH TRAUMAFIX SYSTEM	2005-12-07
PMN K022065 | JEC SINTEA FACTORY S.r.l.	MODEL TFX.00.00.	2005-12-07
PMN K043355 | MNI SINTEA FACTORY S.r.l.	SINTEA BIOTECH POSTERIOR	2001-10-30
PMN K043355 | MNH SINTEA FACTORY S.r.l.	SINTEA BIOTECH POSTERIOR	2001-10-30
PMN K043355 | KWP SINTEA FACTORY S.r.l.	SINTEA BIOTECH POSTERIOR	2001-10-30