BEUDAMED
    FDA Registration Active 🇨🇳 China

    Apex (Guangzhou) Tools & Orthopedics Company

    Reg #: 3007125392 · FEI: 3007125392 · Expires 2026
    View on FDA
    Products
    63
    Proprietary Names
    80
    Establishment Types
    3
    Classifications
    63

    Registration Details

    Registration Name
    Apex (Guangzhou) Tools & Orthopedics Company
    Registration Number
    3007125392
    FEI Number
    3007125392
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    25 Yonghua Road, Yonghe, GETDD
    City
    Guangzhou Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K121004

    Owner / Operator

    Firm Name
    Apex (Guangzhou) Tools & Orthopedics Company
    Operator Number
    10026676
    Address
    Yonghua Road 25, Yonghe, GETDD
    City
    Guangzhou
    State
    Guangdong
    Postal Code
    511356
    Country
    CN
    Correspondent
    Austin Liu

    US Agent

    Business Name
    Marmon Medical Manufacturing, LLC
    Contact Name
    Sean Pettibone
    Address
    181 W Madison St Ste 2500
    City
    Chicago
    State
    IL
    ZIP
    60602
    Country
    US
    Email
    [email protected]
    Phone
    231 3307664

    Products

    Device Name Product Code
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC
    Starter, Bone Screw HWD
    Pin, Fixation, Threaded JDW
    Pin, Fixation, Smooth HTY
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Tamp HXG
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Extractor HWB
    Lavage, Jet FQH
    Tape, Measuring, Rulers And Calipers FTY
    Driver, Surgical, Pin GFC
    Staple, Fixation, Bone JDR
    Accessories, Arthroscopic NBH
    Washer, Bolt Nut HTN
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Trephine HWK
    Rasp, Surgical, General & Plastic Surgery GAC
    Plate, Bone, Growth Control, Pediatric, Epiphysiodesis OBT
    Bag, Drainage, With Adhesive, Ostomy FON
    Guide, Needle, Surgical GDF
    Screwdriver HXX
    Prosthesis, Spinous Process Spacer/Plate NQO
    Reamer HTO
    Orthopedic Stereotaxic Instrument OLO
    Sacroiliac Joint Fixation OUR
    Tap, Bone HWX
    Curette HTF
    Gauge, Depth HTJ
    Thoracolumbosacral Pedicle Screw System NKB
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Stylet, Surgical, General & Plastic Surgery GAH
    Screwdriver, Surgical LRZ
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Pin, Fixation, Smooth, Metallic NDL
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Bit, Surgical GFG
    Impactor HWA
    Bender HXW
    Countersink HWW
    Punch, Surgical LRY
    Orthopedic Manual Surgical Instrument LXH
    Guide, Surgical, Instrument FZX
    Broach HTQ
    Rasp HTR
    Rod, Fixation, Intramedullary And Accessories HSB
    Cutter, Wire HXZ
    Tray, Surgical, Instrument FSM
    Syringe, Irrigating (Non Dental) KYZ
    Appliance, Fixation, Spinal Interlaminal KWP
    Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment KIJ
    Mallet HXL
    Awl HWJ
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Guide, Drill, Ligament LXI
    Retractor GAD
    Support, Patient Position CCX
    Wrench HXC
    Osteotome, Manual GFI
    Instrument, Compression HWN
    Bit, Drill HTW

    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 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 Apexwoundcare Irrigation Pulsar II AWI Irrigation Advanced Wound Irrigation APEX iTOOL 01-1402-0232 osteomed acumed Apexitool, Smith & Nephew Sacroiliac Fixation System Screwdriver, surgical TriMed Orthopediatrics K-WIRE 0.7MM, 80MM WIRE-0.7/080 PediLoc Fragment System ADVANCE 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 AVN® Guide Plate System GEO Staple System 01-1001-0504 PediFlex clamp guide, 4.Xmm 01-1001-0503 PediFlex clamp guide, 3.Xmm ApexWoundCare Guide Wire SLOTTED MALLET AVN® Mallet CS-19-5-Orthex SB Number Clip #5 BLUE C915-CW-07-Wrench, Orthex Wrench 7mm CS-19-4-Orthex SB Number Clip #4 GREEN CS-19-3-Orthex SB Number Clip #3 GOLD CS-19-6-Orthex SB Number Clip #6 VIOLET CS-19-2-Orthex SB Number Clip #2 ORANGE C915-90-07-Wrench, SB 90 cannulated CS-19-1-Orthex SB Number Clip #1 RED GEO Extremity and Ankle Plating System iTool® ApexKneePositioner, iTOOL PediFlex-Flex Nail T-Handle Inserter Wrench EXTERNAL FIXATION, BONE DISTRACTOR DISTRACTOR BODY AVN® Cannulated Drill Bit

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device