Data / Medical devices / China / Apex (Guangzhou) Tools & Orthopedics Company
Apex (Guangzhou) Tools & Orthopedics Company: FDA-registered device maker in Guangzhou Guangdong, China, 2 510(k) clearances
Apex (Guangzhou) Tools & Orthopedics Company is registered with the FDA (registration 3007125392) in Guangzhou Guangdong, China. It lists 61 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 24, 2012. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3007125392
- Address
- 25 Yonghua Road Yonghe, GETDD, Guangzhou Guangdong, China, 511356
- Owner or operator
- Apex (Guangzhou) Tools & Orthopedics Company (10026676)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- August 11, 2008
- Registered through
- 2027
- Brand names listed
- 01-1001-0503 PediFlex clamp guide, 3.Xmm, 01-1001-0504 PediFlex clamp guide, 4.Xmm, 01-1402-0232, 105-01-00: RATCHETING HANDLE, 105-02-00:Fixed Quick Handle, 105-03-00:RATCHETING HANDLE WITH SPIN CAP, 105-04-00:RATCHETING T-HANDLE WITH TRI-LOBE ADAPTER, 105-05-00:SMALL RACHET HANDLE and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Accessories, Arthroscopic | NBH | 1 | Contract manufacturer | accessdata.fda.gov |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | 2 | Contract manufacturer | accessdata.fda.gov |
| Appliance, Fixation, Spinal Interlaminal | KWP | 2 | Contract manufacturer | accessdata.fda.gov |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Contract manufacturer | accessdata.fda.gov |
| Awl | HWJ | 1 | Contract manufacturer | accessdata.fda.gov |
| Bag, Drainage, With Adhesive, Ostomy | FON | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Bender | HXW | 1 | Contract manufacturer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Bit, Surgical | GFG | 1 | Contract manufacturer | accessdata.fda.gov |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | 1 | Contract manufacturer | accessdata.fda.gov |
| Broach | HTQ | 1 | Contract manufacturer | accessdata.fda.gov |
| Countersink | HWW | 1 | Contract manufacturer | accessdata.fda.gov |
| Curette | HTF | 1 | Contract manufacturer | accessdata.fda.gov |
| Cutter, Wire | HXZ | 1 | Contract manufacturer | accessdata.fda.gov |
| Driver, Surgical, Pin | GFC | 1 | Contract manufacturer | accessdata.fda.gov |
| Extractor | HWB | 1 | Contract manufacturer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Contract manufacturer | accessdata.fda.gov |
| Guide, Drill, Ligament | LXI | 1 | Contract manufacturer | accessdata.fda.gov |
| Guide, Needle, Surgical | GDF | 1 | Contract manufacturer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Impactor | HWA | 1 | Contract manufacturer | accessdata.fda.gov |
| Instrument, Compression | HWN | 1 | Contract manufacturer | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 | Contract manufacturer | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | KIJ | 1 | Contract manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Contract manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | 2 | Contract manufacturer | accessdata.fda.gov |
| Lavage, Jet | FQH | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Mallet | HXL | 1 | Contract manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Contract manufacturer | accessdata.fda.gov |
| Orthosis, Spinal Pedicle Fixation | MNI | 2 | Contract manufacturer | accessdata.fda.gov |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | 2 | Contract manufacturer | accessdata.fda.gov |
| Osteotome, Manual | GFI | 1 | Contract manufacturer | accessdata.fda.gov |
| Pin, Fixation, Smooth | HTY | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Pin, Fixation, Smooth, Metallic | NDL | 2 | Contract manufacturer | accessdata.fda.gov |
| Pin, Fixation, Threaded | JDW | 2 | Manufacturer | accessdata.fda.gov |
| Plate, Bone, Growth Control, Pediatric, Epiphysiodesis | OBT | 2 | Contract manufacturer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Contract manufacturer | accessdata.fda.gov |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | 2 | Contract manufacturer | accessdata.fda.gov |
| Punch, Surgical | LRY | 1 | Contract manufacturer | accessdata.fda.gov |
| Rasp | HTR | 1 | Contract manufacturer | accessdata.fda.gov |
| Rasp, Surgical, General & Plastic Surgery | GAC | 1 | Contract manufacturer | accessdata.fda.gov |
| Reamer | HTO | 1 | Contract manufacturer | accessdata.fda.gov |
| Retractor | GAD | 1 | Contract manufacturer | accessdata.fda.gov |
| Rod, Fixation, Intramedullary And Accessories | HSB | 2 | Contract manufacturer | accessdata.fda.gov |
| Sacroiliac Joint Fixation | OUR | 2 | Contract manufacturer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Contract manufacturer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Contract manufacturer | accessdata.fda.gov |
| Screwdriver, Surgical | LRZ | 1 | Contract manufacturer | accessdata.fda.gov |
| Staple, Fixation, Bone | JDR | 2 | Contract manufacturer | accessdata.fda.gov |
| Starter, Bone Screw | HWD | 1 | Contract manufacturer | accessdata.fda.gov |
| Stylet, Surgical, General & Plastic Surgery | GAH | 1 | Contract manufacturer | accessdata.fda.gov |
| Support, Patient Position | CCX | 1 | Contract manufacturer | accessdata.fda.gov |
| Tamp | HXG | 1 | Contract manufacturer | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Contract manufacturer | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Contract manufacturer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Contract manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Contract manufacturer | accessdata.fda.gov |
| Trephine | HWK | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Washer, Bolt Nut | HTN | 2 | Contract manufacturer | accessdata.fda.gov |
| Wrench | HXC | 1 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|
| April 24, 2012 | K121004 | APEX KIRSCHNER WIRES AND STEINMANN PINS | HTY | Substantially Equivalent | Apex Tools & Orthopedics Co. | accessdata.fda.gov |
| October 11, 2011 | K112254 | APEX KIRSCHNER WIRES AND STEINMANN PINS | HTY | Substantially Equivalent | Apex Tools & Orthopedics Co. | accessdata.fda.gov |
Compare with other makers
Updated April 24, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.