Frequently Asked Questions

Ortix Medical Devices Co., Ltd. is a direct original equipment manufacturer (OEM) specializing in spine, trauma, joint, sports medicine, and CMF implants along with matching surgical instrument sets.

We operate an integrated 60,000 m² manufacturing plant equipped with 450+ high-precision CNC multi-axis milling and turning machines, automated wire-cutting tools, and surface processing lines. All engineering design, precision machining, passivation, cleanroom assembly, and packaging are handled entirely in-house under strict quality controls.

Our operational management adheres strictly to ISO 13485 quality system standards, and our facility is registered with the U.S. FDA.

To assist qualified global distributors with local market registration and hospital tender submissions, we provide comprehensive technical dossiers including raw material heat certificates (ASTM F136 / ISO 5832-3 Ti-6Al-4V ELI titanium alloy, 316L stainless steel, PEEK), mechanical static and dynamic fatigue test reports, dimensional validation records, and biocompatibility verification reports.

We provide standard, transparent international trade payment terms to safeguard buyer operations. Accepted payment mechanisms include Telegraphic Transfer (T/T), confirmed Letter of Credit at sight (L/C), PayPal for evaluation sample fees, and Western Union.

For long-term contractual distributors and scheduled contract manufacturing projects, customized credit terms and staged payment structures can be finalized following credit assessment.

Production turnaround depends on item availability, order size, and branding requirements:

• Standard catalog inventory: Dispatched within 4 to 7 business days.
• Out-of-stock items & batch reorders: Typically 15 to 25 calendar days.
• OEM private-label & custom engineering projects: 20 to 35 calendar days following final blueprint and prototype sign-off.

We partner with leading global freight forwarders to provide air express, air cargo, and ocean freight shipping based on order volume and urgency.

Every shipment is packaged in heavy-duty export cartons or wooden crates containing protective moisture barrier wraps and shock-absorbing lining to guarantee product integrity during transit.

Yes. Ortix Medical Devices Co., Ltd. encourages evaluation samples to allow surgical teams and biomedical engineers to verify machining accuracy, surface finish, anodization quality, and instrument compatibility.

Distributors can request sample packages across spine plates, pedicle screws, intramedullary nails, or fusion cages. Sample units are supplied promptly, with express freight charges covered by the buyer.

Yes. Our dedicated OEM/ODM division comprises over 70 R&D engineers capable of custom product development, reverse engineering from physical samples, and CAD/CAM optimization.

Whether you require customized screw thread profiles, unique anatomical locking plate bends, modified instrument tray layouts, or custom laser logo marking, our engineering team manages complete prototype development and mass production.

Our quality assurance standard follows a rigorous multi-gate inspection workflow:

1. Incoming Material Inspection: Spectrographic chemical testing and ultrasonic flaw detection on raw metal bars.
2. In-Process Quality Control (IPQC): First-piece CMM inspection and periodic dimensional checks during CNC machining.
3. Mechanical Integrity Testing: Pull-out strength, axial compression, and torsional testing in our certified testing laboratory.
4. Final Inspection (FQC): 100% optical surface check, cleaning validation, and batch lot tracking documentation prior to dispatch.

We stand firmly behind the quality of every surgical device produced by Ortix Medical Devices Co., Ltd.

We provide technical literature, surgical technique manuals, replacement component guarantees for surgical instrument kits, and rapid engineering consultation. In the rare event of a manufacturing discrepancy, our customer technical support team guarantees root-cause analysis and replacement resolution within 48 hours.