Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007125392

FEI Number

3007125392

Entity Name

Apex (Guangzhou) Tools & Orthopedics Company

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

25 Yonghua Road, Yonghe, GETDD, Guangzhou Guangdong 511356, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Apex (Guangzhou) Tools & Orthopedics Company (Owner Number: 10026676)

Owner / Operator Contact Address

Yonghua Road 25, Yonghe, GETDD, Guangzhou, CN-GD 511356, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Stryker Apex iTool Apex iTool Acumed Tamp AVN® Autogenous Bone Collection Pusher GEO Hammertoe Screw (Tyber Medical) Extractors APEXPULSE Pulsar II AWI Disposable Pulse Irrigation Kits Pulsar II-S SmartPulse Pulse Lavage Fan - Spray Kit PULSAR II Z KI-39-710,K-WRIE RULER Instratek, Stryker Stryker GEO Bone Screw System 910-CW-10L-Wrench, Cannulated 10mm 650-07-Washer, Conical set (T&B) AVN® Trephine 10MM BONE GRAFT DRILL 6MM BONE GRAFT DRILL 8MM BONE GRAFT DRILL Apex iTool Apexwoundcare Irrigation Pulsar II AWI Irrigation Advanced Wound Irrigation PULSAR II APEX iTOOL 01-1402-0232 osteomed acumed Apexitool, Smith & Nephew Sacroiliac Fixation System acumed Acumed Apex iTool GEO Bone Screw System Screwdriver, surgical TriMed Orthopediatrics K-WIRE 0.7MM, 80MM WIRE-0.7/080 APEX iTOOL PediLoc Fragment System ADVANCE acumed GEO 1st MTP Joint Arthrodesis Plating System AVN APEXAVN Avascular Necrosis Core Decompression System 106-01-04:TORQUE LIMITING HANDLE, AO/QCK CONNECT, 0.4NM AVN® Packaging Case 105-04-00:RATCHETING T-HANDLE WITH TRI-LOBE ADAPTER 105-06-00:LARGE RATCHET HANDLE WITH TRI LOBE COUPLING 105-05-00:SMALL RACHET HANDLE 106-00-01:TORQUE LIMITING HANDLE, MINI CONNECT, 0.15NM 105-01-00: RATCHETING HANDLE 105-03-00:RATCHETING HANDLE WITH SPIN CAP 105-02-00:Fixed Quick Handle 106-01-15:TORQUE LIMITING HANDLE, AO/QCK CONNECT, 1.5NM 106-00-02:TORQUE LIMITING HANDLE, MINI CONNECT, 0.2NM 106-01-08:TORQUE LIMITING HANDLE, AO/QCK CONNECT, 0.8NM DRILL,3,CANNULATED, AO Orthopediatrics AVN® Guide Plate System GEO Staple System GEO 1st MTP Joint Arthrodesis Plating System TriMed Orthopediatrics Orthopediatrics Orthopediatrics Orthopediatrics

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-12-03
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-12-03
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-03-04
HWD	Starter, Bone Screw	Orthopedic	Class 1	888.4540	2008-08-11
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2012-05-09
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2012-05-09
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2013-03-04
HXG	Tamp	Orthopedic	Class 1	888.4540	2020-11-20
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-06-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-12-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-04-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-06-05
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2024-09-27
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-09-27
HWB	Extractor	Orthopedic	Class 1	888.4540	2020-11-20
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2009-10-27
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2023-01-17
GFC	Driver, Surgical, Pin	General, Plastic Surgery	Class 1	878.4820	2020-11-24
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2017-08-04
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2017-07-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-12-05
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2023-12-05
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2023-08-11
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-06-05
HWK	Trephine	Orthopedic	Class 1	888.4540	2021-11-21
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-02-24
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-12-03
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-12-03
OBT	Plate, Bone, Growth Control, Pediatric, Epiphysiodesis	Orthopedic	Class 2	888.3030	2018-12-03
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2016-11-30
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-03-04
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2024-09-27
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2011-05-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-11-23
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2008-08-11
NQO	Prosthesis, Spinous Process Spacer/Plate	Unknown	Class 3	N/A	2019-10-20
HTO	Reamer	Orthopedic	Class 1	888.4540	2012-02-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-09-26
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-09-26
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2024-09-26
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2008-08-11
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-06-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-06-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-06-05
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2025-04-23
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2013-03-04
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2011-10-19
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2011-10-19
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-09-27
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2024-09-27
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2024-09-27
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-06-05
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-09-27
GAH	Stylet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2020-11-23
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2023-12-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-12-05
LRZ	Screwdriver, Surgical	General, Plastic Surgery	Class 1	878.4800	2023-12-25
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-10-17
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2019-04-08
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2020-06-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-03-04
NDL	Pin, Fixation, Smooth, Metallic	Orthopedic	Class 2	888.3040	2023-07-26
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2011-05-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-01-08
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2015-01-08
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2015-01-08
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-01-08
GFG	Bit, Surgical	General, Plastic Surgery	Class 1	878.4820	2020-04-20
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2024-09-27
HWA	Impactor	Orthopedic	Class 1	888.4540	2015-02-05
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2024-07-31
HXW	Bender	Orthopedic	Class 1	888.4540	2008-08-11
HWW	Countersink	Orthopedic	Class 1	888.4540	2020-06-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-12-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-12-05
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-09-09
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2008-08-11
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2019-04-08
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-12-05
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-09-27
HTQ	Broach	Orthopedic	Class 1	888.4540	2020-06-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-12-04
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-12-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-10-17
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2026-04-17
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2018-12-03
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-02-13
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-02-13
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2019-04-08
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2019-03-27

Official Correspondent

Austin Liu

US Agent Details

Sean Pettibone Business: Marmon Medical Manufacturing, LLC Email: sean.pettibone@precisionedge.com Phone: (231) 3307664

Related Public Records

Same Entity

Apex (Guangzhou) Tools & Orthopedics Company

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29
K190842	Jiangsu Trauhui Medical Instrument Co., Ltd.	Comus Locking Plate systems	2020-02-03
K130510	Arthrex, Inc.	ARTHREX COMPRESSION PLATES	2013-09-25
K202803	Newclip Technics	Activmotion S DTO	2021-12-16
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007125392. Last updated year: 2026. Please use registration number 3007125392 when referencing this establishment in official correspondence.