Apex (Guangzhou) Tools & Orthopedics Company
Manufacturer and brand owner in Guangzhou, Guangdong, China. 62 device types, 8 products catalogued.
Apex (Guangzhou) Tools & Orthopedics Company is a contract manufacturer holding a current FDA establishment registration. The registration covers Awl, Rasp and 60 other device types. 8 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2008.
62device types registered with the FDA
8products catalogued under its own name
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3007125392 |
| FEI number | 3007125392 |
| DUNS | 529936792 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 艾派（广州）医疗器械有限公司 |
|---|---|
| Unified social credit code | 91440101769526562N |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Guangzhou |
|---|---|
| Province | Guangdong |
| Address | 25 Yonghua Road |
| Postal code | 511356 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Arthroscopic | Class 1 | Stryker | 2017 | 14 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Class 2 | PediLoc Fragment System, 650-07-Washer, Conical set (T&B), 910-CW-10L-Wrench, Cannulated 10mm, CS-19-3-Orthex SB Number Clip #3 GOLD, CS-19-1-Orthex SB Number Clip #1 RED, CS-19-2-Orthex SB Number Clip #2 ORANGE and 6 more | 2015 | 17 |
| Appliance, Fixation, Spinal Interlaminal | Class 2 | 2024 | 11 | |
| Appliance, Fixation, Spinal Intervertebral Body | Class 2 | 2024 | 14 | |
| Awl | Class 1 | Apex iTool | 2008 | 13 |
| Bag, Drainage, With Adhesive, Ostomy | Class 1 | Apexwoundcare Irrigation, Advanced Wound Irrigation, Pulsar II AWI Irrigation, Pulsar II | 2016 | 49 |
| Bender | Class 1 | acumed | 2008 | 10 |
| Bit, Drill | Class 1 | AVN® Cannulated Drill Bit, Apex iTool | 2008 | 27 |
| Bit, Surgical | Class 1 | 2020 | 6 | |
| Blade, Saw, General & Plastic Surgery, Surgical | Class 1 | APEX iTOOL | 2011 | 25 |
| Broach | Class 1 | 2020 | 12 | |
| Countersink | Class 1 | 2020 | 5 | |
| Curette | Class 1 | 2025 | 11 | |
| Cutter, Wire | Class 1 | Orthopediatrics | 2019 | 10 |
| Driver, Surgical, Pin | Class 1 | 2020 | 12 | |
| Extractor | Class 1 | Extractors | 2020 | 15 |
| Gauge, Depth | Class 1 | Acumed | 2013 | 14 |
| Guide, Drill, Ligament | Class 1 | iTool® | 2021 | 3 |
| Guide, Needle, Surgical | Class 1 | APEX iTOOL | 2011 | 32 |
| Guide, Surgical, Instrument | Class 1 | Subtalar Arthroereisis, Counterforce Sleeve, Orthopediatrics, AVN® Guide Plate System | 2019 | 26 |
| Impactor | Class 1 | Advance | 2015 | 18 |
| Instrument, Compression | Class 1 | 2020 | 8 | |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Class 1 | 2020 | 23 | |
| Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | Class 1 | Guide Wire | 2019 | 10 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | Class 2 | 2021 | 14 | |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | Class 2 | 2024 | 5 | |
| Lavage, Jet | Class 2 | Apexpulse, Pulsar II AWI, Disposable Pulse Irrigation Kits, SmartPulse, Pulsar II-S, Pulse Lavage Fan – Spray Kit and 1 more | 2009 | 17 |
| Mallet | Class 1 | Slotted Mallet, AVN® Mallet | 2019 | 6 |
| Orthopedic Manual Surgical Instrument | Class 1 | Subtalar Arthroereisis, Soft Tissue Dilator, ?6mm, Avascular Necrosis Core Decompression System, AVN, Apexavn, 106-00-01:TORQUE Limiting Handle, Mini Connect, 0.15NM, 105-06-00:LARGE Ratchet Handle With TRI Lobe Coupling and 11 more | 2008 | 53 |
| Orthopedic Stereotaxic Instrument | Class 2 | Sacroiliac Fixation System | 2024 | 5 |
| Orthosis, Spinal Pedicle Fixation | Class 2 | 2024 | 13 | |
| Orthosis, Spondylolisthesis Spinal Fixation | Class 2 | 2024 | 13 | |
| Osteotome, Manual | Class 1 | Apex iTool, iTool | 2014 | 4 |
| Pin, Fixation, Smooth | Class 2 | Apex iTool, Apex, iTool, Orthopediatrics | 2011 | 12 |
| Pin, Fixation, Smooth, Metallic | Class 2 | WIRE-0.7/080, K-Wire 0.7MM, 80MM | 2023 | 2 |
| Pin, Fixation, Threaded | Class 2 | Apex iTool, Apex, iTool | 2011 | 9 |
| Plate, Bone, Growth Control, Pediatric, Epiphysiodesis | Class 2 | 2018 | 2 | |
| Plate, Fixation, Bone | Class 2 | GEO Extremity and Ankle Plating System, GEO 1st MTP Joint Arthrodesis Plating System, Orthopediatrics, TriMed, PediLoc Fragment System | 2013 | 22 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Class 2 | Acumed | 2013 | 8 |
| Punch, Surgical | Class 1 | 2024 | 9 | |
| Rasp | Class 1 | 2026 | 12 | |
| Rasp, Surgical, General & Plastic Surgery | Class 1 | Apex iTool | 2012 | 6 |
| Reamer | Class 1 | Apexitool, Smith & Nephew | 2012 | 23 |
| Retractor | Class 1 | 2020 | 34 | |
| Rod, Fixation, Intramedullary And Accessories | Class 2 | Orthopediatrics | 2018 | 17 |
| Sacroiliac Joint Fixation | Class 2 | Sacroiliac Fixation System | 2024 | 3 |
| Screw, Fixation, Bone | Class 2 | Orthopediatrics, GEO Hammertoe Screw (Tyber Medical), GEO 1st MTP Joint Arthrodesis Plating System, TriMed, PediLoc Fragment System, GEO Bone Screw System and 2 more | 2013 | 31 |
| Screwdriver | Class 1 | acumed, osteomed | 2008 | 18 |
| Screwdriver, Surgical | Class 1 | Screwdriver, surgical | 2023 | 1 |
| Staple, Fixation, Bone | Class 2 | GEO Staple System, Instratek, Stryker | 2017 | 7 |
| Starter, Bone Screw | Class 1 | Stryker | 2008 | 4 |
| Stylet, Surgical, General & Plastic Surgery | Class 1 | 2020 | 3 | |
| Support, Patient Position | Class 1 | ApexKneePositioner, iTOOL | 2013 | 66 |
| Syringe, Irrigating (Non Dental) | Class 1 | ApexWoundCare | 2015 | 110 |
| Tamp | Class 1 | Tamp, AVN® Autogenous Bone Collection Pusher | 2020 | 7 |
| Tap, Bone | Class 1 | acumed | 2008 | 12 |
| Tape, Measuring, Rulers And Calipers | Class 1 | Z KI-39-710,K-WRIE Ruler | 2023 | 42 |
| Thoracolumbosacral Pedicle Screw System | Class 2 | 2024 | 15 | |
| Tray, Surgical, Instrument | Class 1 | 01-1001-0503 PediFlex clamp guide, 3.Xmm, 01-1001-0504 PediFlex clamp guide, 4.Xmm | 2023 | 105 |
| Trephine | Class 1 | 8MM Bone Graft Drill, AVN® Trephine, 10MM Bone Graft Drill, 6MM Bone Graft Drill | 2021 | 6 |
| Washer, Bolt Nut | Class 2 | PediLoc Fragment System, GEO Bone Screw System | 2015 | 9 |
| Wrench | Class 1 | PediFlex-Flex Nail T-Handle Inserter Wrench | 2024 | 14 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| AWI | FQH | 18 |
| AWI | FON | 14 |
| itool® ApexPulse™ | FQH | 11 |
| Microaire® | FQH | 11 |
| iTool® | HTY | 10 |
| Itool | FQH | 4 |
| iTool® | HWK | 3 |
| MicroPort® | FQH | 3 |
Clearances
No clearance names Apex (Guangzhou) Tools & Orthopedics Company as applicant. 2 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K121004 | 2012-04-24 | HTY | Special | Apex Tools & Orthopedics Co. |
| K112254 | 2011-10-11 | HTY | Traditional | Apex Tools & Orthopedics Co. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2005 |
|---|---|
| Main products | surgical instruments, orthopedic instruments, trauma care systems, wound care systems |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.