Lx Precision Shanghai Co L T D

FDA Filings

This page includes the latest FDA filings for Lx Precision Shanghai Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3008791302
• FEI Number: 3008791302
• Name: Michael Van Der Woude
• Owner & Operator: LX PRECISION SHANGHAI CO LTD
• Contact Address: No.8, Lane 88, Yuanshan Rd. Minhang Dist.; Shanghai CN-31 Shanghai 201108 CN
• Official Correspondent:
  • Leehom Shen
  • 86-21-6442-2578
• US Agent:
  • Michael Van Der Woude
  • Emergo
  • 512 3279997
  • USAgent@ul.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2500 Bee Cave Road Building One, Suite 300; Austin, TX 78746 US
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K152326 | JEY Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	OmniMax MMF	2019-08-22
PMN K152326 | DZL Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	OmniMax MMF	2019-08-22
PMN K143336 | JEY Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	OmniMax MMF System, OmniMax MMF System	2019-08-22
PMN K143336 | DZL Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	OmniMax MMF System, OmniMax MMF System	2019-08-22
PMN K031751 | HWC Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	Self Drilling Screw RapidFire	2019-08-22
PMN K953385 | JEY Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	Neuro System	2019-07-01
PMN K953385 | JEY Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	CMF System	2019-07-01
PMN K953385 | JEY Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	2.0mm System	2019-07-01
PMN K953385 | JEY Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	1.5mm System	2019-07-01
PMN K953385 | JEY Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	1.0mm System	2019-07-01
PMN K121624 | HBW Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	CranioCurve	2019-07-01
PMN K121624 | HBW Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	Biomet Microfixation Neuro Plating System	2019-07-01
PMN K121624 | HBW Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	1.5mm System	2019-07-01
PMN K121624 | HBW Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	1.0mm System	2019-07-01
PMN K121624 | GXR Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	CranioCurve	2019-07-01
PMN K121624 | GXR Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	Biomet Microfixation Neuro Plating System	2019-07-01
PMN K121624 | GXR Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	1.5mm System	2019-07-01
PMN K121624 | GXR Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	1.0mm System	2019-07-01
PMN K121624 | GWO Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	CranioCurve	2019-07-01
PMN K121624 | GWO Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	Biomet Microfixation Neuro Plating System	2019-07-01
PMN K121624 | GWO Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	1.5mm System	2019-07-01
PMN K121624 | GWO Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	1.0mm System	2019-07-01
PMN K081067 | JEY Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	TraumaOne System	2019-07-01
PMN K983728 | DZL Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	2X9MM T1 SD IMF SCREW	2018-04-13
PMN K983728 | DZL Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	2X7MM T1 SD IMF SCREW	2018-04-13
PMN K983728 | DZL Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	2X15MM IMF SCREW	2018-04-13
PMN K983728 | DZL Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	2X11MM T1 SD IMF SCREW	2018-04-13
PMN K983728 | DZL Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	2.0 X 13MM IMF SCREW	2018-04-13
PMN K121589 | JEY Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	2.0mm System	2018-04-13
PMN K121589 | JEY Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	1.65X5MM HT SD X-DR SCR	2018-04-13
PMN K121589 | JEY Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	1.65 X 7MM HT SD X-DRIVE	2018-04-13
PMN K121589 | JEY Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	1.65 X 6MM SD X-DRIVE SCREW	2018-04-13
PMN K121589 | JEY Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	1.5mm System	2018-04-13
PMN K121589 | JEY Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	1.5X7MM HT SD X-DR SCR	2018-04-13
PMN K121589 | JEY Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	1.5X6MM HT SD X-DR SCR	2018-04-13
PMN K121589 | JEY Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	1.5X5MM HT SD X-DR SCR	2018-04-13
PMN K121589 | JEY Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	1.5X4MM X-DRIVE TF SD SCREW	2018-04-13
PMN K121589 | JEY Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	1.5X4MM HT SD X-DR SCR	2018-04-13
PMN K121589 | JEY Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	1.5X3.5MM X-DRIVE TF SD SCREW	2018-04-13
PMN K121589 | JEY Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	1.5X3.5MM HT SD X-DR SCR	2018-04-13
PMN K121589 | JEY Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	1.0mm System	2018-04-13
PMN K040983 | DZE Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	2X9MM SD IMF SCREW	2018-04-13
PMN K040983 | DZE Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	2X7MM SD IMF SCREW	2018-04-13
PMN K040983 | DZE Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	2X5MM SD IMF SCREW	2018-04-13
PMN K040983 | DZE Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	2X11MM SD IMF SCREW	2018-04-13
PMN K013227 | DZE Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	Zimmer Biomet	2016-09-23
PMN K011245 | DZE Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	Zimmer Biomet	2016-09-23
PMN K002188 | DZE Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	Zimmer Biomet	2016-09-23
PMN K063286 | DZE Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	Zimmer Biomet	2016-09-21
PMN K992367 | HWC Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	Zimmer Biomet	2016-09-09
PMN K951357 | KTT Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	Zimmer Biomet	2016-09-09
PMN K032895 | MBF Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	Zimmer Biomet	2016-09-09
PMN K023399 | KTT Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	Zimmer Biomet	2016-09-09
PMN K010551 | NDF Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	Zimmer Biomet	2016-09-09
PMN K874670 | HWC Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	Cann Cort Bone Screw	2016-08-22
PMN K972444 | DZE Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	Biomet 3i Abutment Retaining Screws	2016-02-04
PMN K072642 | NHA Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	BIOMET 3i Dental Abutments	2011-09-22
PMN K981483 | KTT Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	EBI DFS? Joint Fixator	2011-06-13
PMN K072161 | HSB Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	Biomet? Femoral Locking Nail System	2011-06-13
PMN K063570 | HSB Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	Biomet? Tibial Locking Nail System	2011-06-13
PMN K023133 | KWQ Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	EBI VueLockTM Anterior Cervical Plate System	2011-06-13
PMN K014194 | KTT Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	EBI? XFIX? Vision? Fixation System	2011-06-13
PMN K010437 | KTT Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	EBI XFIX? DFS? Rail System	2011-06-13
PMN K001794 | KWQ Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	EBI Anterior Cervical Plate System	2011-06-13
PMN K953406 | KTT Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	EBI X FIX DYNAFIX SYSTEM (DFS)	2011-05-24
PMN K093761 | HWC Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	OptiLock? VL Distal Radius Plating System	2011-05-20
PMN K082874 | HWC Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	BioDrive? Cannulated Screw System	2011-05-17
PMN K061098 | HRS Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	FBI? OptiLock? Periarticular Plating System	2011-05-17
NDP Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	BIOMET 3i Dental Abutments	2011-01-25
PMN K082187 | KWQ Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	Biomet Lumbar Plate System	2011-01-20
PMN K080646 | KWQ Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	C-Tek? MaxAnTM Anterior Cervical Plate System	2011-01-20
PMN K062494 | HRS Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	EBI? OptiLock Upper Extremity Plating System	2011-01-20
PMN K042237 | HRS Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	EBI? Periarticular Plating System	2011-01-20
PMN K040908 | HRS Michael Van Der Woude [LX PRECISION SHANGHAI CO LTD]	EBI? Distal Radius Plating System	2011-01-20