Changzhou Orthmed Medical Instrument Co L T D

FDA Filings

This page includes the latest FDA filings for Changzhou Orthmed Medical Instrument 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: 3005596372
• FEI Number: 3005596372
• Name: CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD.
• Owner & Operator: STRYKER CORP.
• Contact Address: 1901 Romence Pkwy ; Portage MI 49002 US
• US Agent:
  • Meg Smith
  • Howmedica Osteonics Corp.
  • 201 8315014
  • Meg.smith@stryker.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: NO. 177 QINLING ROAD XINBEI DISTRICT; CHANGZHOU, JIANGSU Jiangsu, 213022 CN
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K143393 | MBH CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. [STRYKER CORP.]	Triathlon Cone Implants; Triathlon Cone Instruments; Additional Triathlon Instruments	2015-02-18
PMN K143393 | JWH CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. [STRYKER CORP.]	Triathlon Cone Implants; Triathlon Cone Instruments; Additional Triathlon Instruments	2015-02-18
PMN K141056 | MBH CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. [STRYKER CORP.]	Triathlon Knee System	2014-11-24
PMN K141056 | MBH CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. [STRYKER CORP.]	Triathlon Knee System Instrumentation	2014-11-24
PMN K141056 | JWH CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. [STRYKER CORP.]	Triathlon Knee System	2014-11-24
PMN K141056 | JWH CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. [STRYKER CORP.]	Triathlon Knee System Instrumentation	2014-11-24
PMN K132624 | MBH CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. [STRYKER CORP.]	Triathlon Tritanium Metal-Backed Patella	2013-12-11
PMN K132624 | MBH CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. [STRYKER CORP.]	Triathlon Single-Use Instrumentation	2013-12-11
PMN K132624 | MBH CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. [STRYKER CORP.]	Triathlon Knee System Instrumentation	2013-12-11
PMN K132624 | JWH CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. [STRYKER CORP.]	Triathlon Tritanium Metal-Backed Patella	2013-12-11
PMN K132624 | JWH CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. [STRYKER CORP.]	Triathlon Single-Use Instrumentation	2013-12-11
PMN K132624 | JWH CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. [STRYKER CORP.]	Triathlon Knee System Instrumentation	2013-12-11
PMN K123486 | MBH CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. [STRYKER CORP.]	Triathlon Knee System	2013-05-20
PMN K123486 | MBH CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. [STRYKER CORP.]	Triathlon Knee System Instrumentation	2013-05-20
PMN K123486 | JWH CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. [STRYKER CORP.]	Triathlon Knee System	2013-05-20
PMN K123486 | JWH CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. [STRYKER CORP.]	Triathlon Knee System Instrumentation	2013-05-20
PMN K123166 | JWH CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. [STRYKER CORP.]	Triathlon Knee System	2013-03-15
PMN K123166 | JWH CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. [STRYKER CORP.]	Triathlon Knee System Instrumentation	2013-03-15
PMN K111690 CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD.	DEVINE SPINAL SYSTEM	2011-11-22
PMN K101400 CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD.	LOCKING COMPRESSION PLATE	2010-11-09