Apex Guangzhou Tools Orthopedics Co

FDA Filings

This page includes the latest FDA filings for Apex Guangzhou Tools Orthopedics Co. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3015491732
• FEI Number: 3015491732
• Name: Chris Smith
• Owner & Operator: Apex (Guangzhou) Tools & Orthopedics Company
• Contact Address: Yonghua Road 25 Yonghe, GETDD; Guangzhou CN-44 Guangdong 511356 CN
• Official Correspondent:
  • Scott Liang
  • 86-20-82986918-112
• US Agent:
  • Chris Smith
  • 312 9801104
  • Chris.Smith@ColsonAssociates.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: One North Franklin, Suite 2420 ; Chicago, IL 60606 US
• Establishment Type:
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility

• Registration Number: 3007125392
• FEI Number: 3007125392
• Name: Apex (Guangzhou) Tools & Orthopedics Company
• Owner & Operator: Apex (Guangzhou) Tools & Orthopedics Company
• Contact Address: Yonghua Road 25 Yonghe, GETDD; Guangzhou CN-44 Guangdong 511356 CN
• Official Correspondent:
  • Scott Liang
  • 86-20-82986918-112
• US Agent:
  • Chris Smith
  • Colson Associates, Inc
  • 312 9801104
  • Chris.Smith@ColsonAssociates.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 25 Yonghua Road Yonghe, GETDD; Guangzhou Guangdong, 511356 CN
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Export Device to the United States But Perform No Other Operation on Device
  • Manufacture Medical Device
  • Remanufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
GUDID 06957277202610 Apex (Guangzhou) Tools & Orthopedics Co.	AWI	2024-03-14
GUDID 06957277202603 Apex (Guangzhou) Tools & Orthopedics Co.	AWI	2024-03-14
GUDID 16957277200354 Apex (Guangzhou) Tools & Orthopedics Co.	AWI 209-00-68	2023-08-21
GUDID 16957277201597 Apex (Guangzhou) Tools & Orthopedics Co.	AWI 210-02	2022-03-10
GUDID 16957277201580 Apex (Guangzhou) Tools & Orthopedics Co.	AWI 210-01	2022-03-10
GUDID 16957277200958 Apex (Guangzhou) Tools & Orthopedics Co.	ITOOL 209-02	2021-04-08
GUDID 16957277200927 Apex (Guangzhou) Tools & Orthopedics Co.	ITOOL 209-01	2021-04-08
GUDID 16957277200804 Apex (Guangzhou) Tools & Orthopedics Co.	AWI 210-07	2021-04-08
GUDID 16957277200774 Apex (Guangzhou) Tools & Orthopedics Co.	AWI 209-06	2021-04-08
GUDID 16957277200743 Apex (Guangzhou) Tools & Orthopedics Co.	AWI 209-05	2021-04-08
GUDID 16957277200712 Apex (Guangzhou) Tools & Orthopedics Co.	AWI 209-04	2021-04-08
GUDID 16957277200682 Apex (Guangzhou) Tools & Orthopedics Co.	AWI 209-03	2021-04-08
GUDID 06957277200968 Apex (Guangzhou) Tools & Orthopedics Co.	ITOOL 209-02	2021-04-08
GUDID 06957277200937 Apex (Guangzhou) Tools & Orthopedics Co.	ITOOL 209-01	2021-04-08
GUDID 06957277200814 Apex (Guangzhou) Tools & Orthopedics Co.	AWI 210-07	2021-04-08
GUDID 06957277200784 Apex (Guangzhou) Tools & Orthopedics Co.	AWI 209-06	2021-04-08
GUDID 06957277200753 Apex (Guangzhou) Tools & Orthopedics Co.	AWI 209-05	2021-04-08
GUDID 06957277200722 Apex (Guangzhou) Tools & Orthopedics Co.	AWI 209-04	2021-04-08
GUDID 06957277200555 Apex (Guangzhou) Tools & Orthopedics Co.	MICROAIRE® 201-00-80	2020-11-06
GUDID 06957277200548 Apex (Guangzhou) Tools & Orthopedics Co.	MICROAIRE® 201-00-52	2020-11-06
GUDID 06957277200531 Apex (Guangzhou) Tools & Orthopedics Co.	MICROAIRE® 201-00-51	2020-11-06
GUDID 06957277200524 Apex (Guangzhou) Tools & Orthopedics Co.	MICROAIRE® 201-00-50	2020-11-06
GUDID 06957277200517 Apex (Guangzhou) Tools & Orthopedics Co.	MICROAIRE® 201-00-46	2020-11-06
GUDID 06957277200500 Apex (Guangzhou) Tools & Orthopedics Co.	MICROAIRE® 201-00-44	2020-11-06
GUDID 06957277200494 Apex (Guangzhou) Tools & Orthopedics Co.	MICROAIRE® 201-00-37	2020-11-06
GUDID 06957277200487 Apex (Guangzhou) Tools & Orthopedics Co.	MICROAIRE® 201-05-00	2020-11-06
GUDID 06957277200470 Apex (Guangzhou) Tools & Orthopedics Co.	MICROAIRE® 201-04-00	2020-11-06
GUDID 06957277200463 Apex (Guangzhou) Tools & Orthopedics Co.	MICROAIRE® 201-03-00	2020-11-06
GUDID 06957277200456 Apex (Guangzhou) Tools & Orthopedics Co.	MICROAIRE® 201-02-00	2020-11-06
GUDID 06957277200449 Apex (Guangzhou) Tools & Orthopedics Co.	AWI	2020-11-06
GUDID 06957277200371 Apex (Guangzhou) Tools & Orthopedics Co.	AWI	2020-11-06
GUDID 06957277200364 Apex (Guangzhou) Tools & Orthopedics Co.	AWI	2020-11-06
GUDID 06957277200357 Apex (Guangzhou) Tools & Orthopedics Co.	AWI	2020-11-06
GUDID 06957277200340 Apex (Guangzhou) Tools & Orthopedics Co.	AWI	2020-11-06
GUDID 06957277200333 Apex (Guangzhou) Tools & Orthopedics Co.	AWI	2020-11-06
GUDID 06957277200326 Apex (Guangzhou) Tools & Orthopedics Co.	AWI	2020-11-06
GUDID 06957277200692 Apex (Guangzhou) Tools & Orthopedics Co.	AWI	2020-03-11
HXL Apex (Guangzhou) Tools & Orthopedics Company	SLOTTED MALLET	2019-09-22
PMN K081097 | HTY Apex (Guangzhou) Tools & Orthopedics Company	Orthopediatrics	2019-04-08
HXZ Apex (Guangzhou) Tools & Orthopedics Company	Orthopediatrics	2019-04-08
FZX Apex (Guangzhou) Tools & Orthopedics Company	Orthopediatrics	2019-04-08
PMN K082375 | HTY Apex (Guangzhou) Tools & Orthopedics Company	Orthopediatrics	2019-03-27
KIJ Apex (Guangzhou) Tools & Orthopedics Company	APEX POWER	2019-03-08
KIJ Apex (Guangzhou) Tools & Orthopedics Company	APEX ITOOL	2019-03-08
PMN K082949 | HWC Apex (Guangzhou) Tools & Orthopedics Company	Orthopediatrics	2019-03-06
GUDID 06957277200203 Apex (Guangzhou) Tools & Orthopedics Co.	MicroPort® 201-00-52	2019-02-21
GUDID 06957277200197 Apex (Guangzhou) Tools & Orthopedics Co.	MicroPort® 2010400	2019-02-21
GUDID 06957277200180 Apex (Guangzhou) Tools & Orthopedics Co.	MicroPort® 2010300	2019-02-21
GUDID 06957277200173 Apex (Guangzhou) Tools & Orthopedics Co.	itool® ApexPulse™ 201-00-80	2019-02-21
GUDID 06957277200166 Apex (Guangzhou) Tools & Orthopedics Co.	itool® ApexPulse™ 201-00-52	2019-02-21
GUDID 06957277200159 Apex (Guangzhou) Tools & Orthopedics Co.	itool® ApexPulse™ 201-00-51	2019-02-21
GUDID 06957277200142 Apex (Guangzhou) Tools & Orthopedics Co.	itool® ApexPulse™ 201-00-50	2019-02-21
GUDID 06957277200135 Apex (Guangzhou) Tools & Orthopedics Co.	itool® ApexPulse™ 201-00-46	2019-02-21
GUDID 06957277200128 Apex (Guangzhou) Tools & Orthopedics Co.	itool® ApexPulse™ 201-00-44	2019-02-21
GUDID 06957277200111 Apex (Guangzhou) Tools & Orthopedics Co.	itool® ApexPulse™ 201-00-37	2019-02-21
GUDID 06957277200104 Apex (Guangzhou) Tools & Orthopedics Co.	itool® ApexPulse™ 201-05-00	2019-02-21
GUDID 06957277200098 Apex (Guangzhou) Tools & Orthopedics Co.	itool® ApexPulse™ 201-04-00	2019-02-21
GUDID 06957277200081 Apex (Guangzhou) Tools & Orthopedics Co.	itool® ApexPulse™ 201-03-00	2019-02-21
GUDID 06957277200074 Apex (Guangzhou) Tools & Orthopedics Co.	itool® ApexPulse™ 201-02-00	2019-02-21
PMN K083726 | HSB Apex (Guangzhou) Tools & Orthopedics Company	Orthopediatrics	2018-12-03
PMN K162321 | JDR Apex (Guangzhou) Tools & Orthopedics Company	Instratek, Stryker	2017-08-04
PMN K940230 | HRX Apex (Guangzhou) Tools & Orthopedics Company	Instratek, Stryker	2017-08-02
PMN K922391 | HRX Apex (Guangzhou) Tools & Orthopedics Company	Instratek, Stryker	2017-08-02
NBH Apex (Guangzhou) Tools & Orthopedics Company	Stryker	2017-07-16
FON Chris Smith [Apex (Guangzhou) Tools & Orthopedics Company]	iTool, Apexwoundcare, Apexwoundcare irrigation system, AWI, Apexwoundcare Irrigation Bag Extremity, WIBE, WIBT	2016-11-30
FON Chris Smith [Apex (Guangzhou) Tools & Orthopedics Company]	Pulsar II AWI Irrigation Bag	2016-11-30
FON Chris Smith [Apex (Guangzhou) Tools & Orthopedics Company]	Apexwoundcare Irrigation Bag Trunk	2016-11-30
FON Chris Smith [Apex (Guangzhou) Tools & Orthopedics Company]	Advanced Wound Irrigation Bag	2016-11-30
FON Apex (Guangzhou) Tools & Orthopedics Company	iTool, Apexwoundcare, Apexwoundcare irrigation system, AWI, Apexwoundcare Irrigation Bag Extremity, WIBE, WIBT	2016-11-30
FON Apex (Guangzhou) Tools & Orthopedics Company	Pulsar II AWI Irrigation Bag	2016-11-30
FON Apex (Guangzhou) Tools & Orthopedics Company	Apexwoundcare Irrigation Bag Trunk	2016-11-30
FON Apex (Guangzhou) Tools & Orthopedics Company	Advanced Wound Irrigation Bag	2016-11-30
KYZ Chris Smith [Apex (Guangzhou) Tools & Orthopedics Company]	ApexWoundCare	2015-09-24
KYZ Apex (Guangzhou) Tools & Orthopedics Company	ApexWoundCare	2015-09-24
HWA Apex (Guangzhou) Tools & Orthopedics Company	ADVANCE	2015-02-05
PMN K140431 | KTT Apex (Guangzhou) Tools & Orthopedics Company	PediLoc Fragment System	2015-01-08
PMN K140431 | HWC Apex (Guangzhou) Tools & Orthopedics Company	PediLoc Fragment System	2015-01-08
PMN K140431 | HTN Apex (Guangzhou) Tools & Orthopedics Company	PediLoc Fragment System	2015-01-08
PMN K140431 | HRS Apex (Guangzhou) Tools & Orthopedics Company	PediLoc Fragment System	2015-01-08
GFI Apex (Guangzhou) Tools & Orthopedics Company	iTool	2014-08-07
GFI Apex (Guangzhou) Tools & Orthopedics Company	Apex iTool	2014-08-07
PMN K083286 | HWC Apex (Guangzhou) Tools & Orthopedics Company	Orthopediatrics	2014-02-13
PMN K083286 | HRS Apex (Guangzhou) Tools & Orthopedics Company	Orthopediatrics	2014-02-13
CCX Apex (Guangzhou) Tools & Orthopedics Company	ApexKneePositioner, iTOOL	2013-12-10
PMN K992525 | HSD Apex (Guangzhou) Tools & Orthopedics Company	Acumed	2013-03-04
HTJ Apex (Guangzhou) Tools & Orthopedics Company	Acumed	2013-03-04
PMN K121004 | JDW Apex (Guangzhou) Tools & Orthopedics Company	iTool	2012-05-09
PMN K121004 | JDW Apex (Guangzhou) Tools & Orthopedics Company	Apex	2012-05-09
PMN K121004 | JDW Apex (Guangzhou) Tools & Orthopedics Company	Apex iTool	2012-05-09
PMN K121004 | HTY Apex (Guangzhou) Tools & Orthopedics Company	iTool	2012-05-09
PMN K121004 | HTY Apex (Guangzhou) Tools & Orthopedics Company	Apex	2012-05-09
PMN K121004 | HTY Apex (Guangzhou) Tools & Orthopedics Company	Apex iTool	2012-05-09
HTO Apex (Guangzhou) Tools & Orthopedics Company	Apexitool, Smith & Nephew	2012-02-24
GDT Apex (Guangzhou) Tools & Orthopedics Company	Apexsuture, iTool	2012-02-24
GAC Apex (Guangzhou) Tools & Orthopedics Company	Apex iTool	2012-02-24
PMN K112254 | JDW Apex (Guangzhou) Tools & Orthopedics Company	Apex iTool	2011-10-19
PMN K112254 | HTY Apex (Guangzhou) Tools & Orthopedics Company	Apex iTool	2011-10-19
GFA Apex (Guangzhou) Tools & Orthopedics Company	APEX iTOOL	2011-05-10
GDF Apex (Guangzhou) Tools & Orthopedics Company	APEX iTOOL	2011-05-10
MDM Apex (Guangzhou) Tools & Orthopedics Company	Apex iTool	2010-06-30
GAG Apex (Guangzhou) Tools & Orthopedics Company	APEXSUTURE	2009-10-27
FQH Chris Smith [Apex (Guangzhou) Tools & Orthopedics Company]	SmartPulse	2009-10-27
FQH Chris Smith [Apex (Guangzhou) Tools & Orthopedics Company]	Pulse Lavage System	2009-10-27
FQH Chris Smith [Apex (Guangzhou) Tools & Orthopedics Company]	Pulsar II AWI	2009-10-27
FQH Chris Smith [Apex (Guangzhou) Tools & Orthopedics Company]	Disposable Pulse Lavages	2009-10-27
FQH Chris Smith [Apex (Guangzhou) Tools & Orthopedics Company]	Disposable Pulse Irrigation Kits	2009-10-27
FQH Chris Smith [Apex (Guangzhou) Tools & Orthopedics Company]	APEXPULSE	2009-10-27
FQH Apex (Guangzhou) Tools & Orthopedics Company	SmartPulse	2009-10-27
FQH Apex (Guangzhou) Tools & Orthopedics Company	Pulse Lavage System	2009-10-27
FQH Apex (Guangzhou) Tools & Orthopedics Company	Pulsar II AWI	2009-10-27
FQH Apex (Guangzhou) Tools & Orthopedics Company	Disposable Pulse Lavages	2009-10-27
FQH Apex (Guangzhou) Tools & Orthopedics Company	Disposable Pulse Irrigation Kits	2009-10-27
FQH Apex (Guangzhou) Tools & Orthopedics Company	APEXPULSE	2009-10-27
LXH Apex (Guangzhou) Tools & Orthopedics Company	Avascular Necrosis Core Decompression System	2008-08-11
LXH Apex (Guangzhou) Tools & Orthopedics Company	AVN	2008-08-11
LXH Apex (Guangzhou) Tools & Orthopedics Company	APEXAVN	2008-08-11
HXX Apex (Guangzhou) Tools & Orthopedics Company	osteomed	2008-08-11
HXX Apex (Guangzhou) Tools & Orthopedics Company	acumed	2008-08-11
HXW Apex (Guangzhou) Tools & Orthopedics Company	acumed	2008-08-11
HWX Apex (Guangzhou) Tools & Orthopedics Company	acumed	2008-08-11
HWJ Apex (Guangzhou) Tools & Orthopedics Company	Apex iTool	2008-08-11
HWD Apex (Guangzhou) Tools & Orthopedics Company	Stryker	2008-08-11
HTW Apex (Guangzhou) Tools & Orthopedics Company	Apex iTool	2008-08-11

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020042713056	Yantian,China (Mainland) -> Norfolk, Virginia	201-03-00MA, MICROAIRE PULSE LAVAGE KNEE KIT 201-04-00MA, MICROAIRE PULSE LAVAGE HIP KIT 2 01-05-00MA, MICROAIRE PULSE LAVAGE FAN SPRAY KIT	960 CTN
2020022514656	Yantian,China (Mainland) -> Norfolk, Virginia	201-03-00MA, MICROAIRE PULSE LAVAGE KNEE KIT, 192CARTONS 201-04-00MA, MICROAIRE PULSE LAVA GE HIP KIT, 672CARTONS 201-05-00MA, MICROAIRE PULSE LAVAGE FAN SPRAY KIT, 96 CARTONS	960 CTN
2019112510671	Yantian,China (Mainland) -> Norfolk, Virginia	201-03-00MA, MICROAIRE PULSE LAVAGE KNEE KIT, 201-04-00MA, MICROAIRE PULSE LAVAGE HIP KIT	960 CTN
2019102111115	Yantian,China (Mainland) -> Norfolk, Virginia	201-03-00MA, MICROAIRE PULSE LAVAGE KNEE KIT, 192CARTONS 201-04-00MA, MICROAIRE PULSE LAVA GE HIP KIT, 768CARTONS	960 CTN
201909264453	Yantian,China (Mainland) -> Norfolk, Virginia	MICROAIRE PULSE LAVAGE KNEE KIT MICROAIRE PUL SE LAVAGE HIP KIT	960 CTN
2019071610264	Yantian,China (Mainland) -> Norfolk, Virginia	201-03-00MA, MICROAIRE PULSE LAVAGE KNEE KIT, 192CARTONS 201-04-00MA, MICROAIRE PULSE LAVA GE HIP KIT, 672CARTONS 201-05-00MA, MICROAIRE PULSE LAVAGE FAN SPRAY KT, 96 CARTONS TOTAL 960 CARTONS PACKED IN 20 PALLETS.	960 CTN
201906114260	Yantian,China (Mainland) -> Norfolk, Virginia	MICROAIRE PULSE LAVAGE KNEE KIT MICROAIRE PUL SE LAVAGE HIP KIT MICROAIRE PULSE LAVAGE FAN SPRAY KT	960 CTN
201905156036	Yantian,China (Mainland) -> Norfolk, Virginia	MICROAIRE PULSE LAVAGE KNEE KIT MICROAIRE PUL SE LAVAGE HIP KIT MICROAIRE PULSE LAVAGE FAN SPRAY KT	960 CTN