Thoracolumbar
CanIVY Pedicle Screw System
Dual-core, dual-thread titanium screws with polyaxial and fenestrated options for cement augmentation in osteoporotic bone.
Professional Spine Solutions
Precision-Engineered Spinal Implants for Global Healthcare Providers
Orthi Medical Co., Ltd. is an ISO 13485-certified manufacturer delivering advanced spinal fixation and reconstruction systems. Engineered to international medical device standards, our spine portfolio provides surgeons with biomechanical stability, reduced intraoperative time, and predictable surgical outcomes.
Cervical Fusion
CanPEEK-Z Cervical Cage
Zero-profile PEEK interbody fusion cage featuring integrated titanium locking screws and radiopaque markers for anatomical alignment.
Cervical Plating
CanACP Anterior Cervical Plate
Ultra-low 2mm profile design with pre-assembled one-step locking mechanism to prevent screw back-out and minimize soft tissue irritation.
MIS Augmentation
CanPKP Kyphoplasty System
Minimally invasive balloon kyphoplasty system designed for height restoration and pain alleviation in osteoporotic compression fractures.
Lumbar Fusion
CanPEEK-T & L Interbody Cages
TLIF/PLIF PEEK interbody spacers with targeted serrated teeth for immediate stability and large graft chambers for accelerated fusion.
Percutaneous Fixation
CanHELP Long-Arm MIS Screws
Long-arm percutaneous pedicle screws tailored for minimally invasive thoracolumbar internal fixation with reduced incision trauma.
Reconstruction
CanMesh Titanium Mesh Cage
Customizable titanium mesh cage system providing structural column support following corpectomy and major tumor reconstruction.
Instrument Trays
CanMIC Tubular Retractor System
Complete minimally invasive channel instrument set with fiber-optic light integration for PLIF/TLIF spine procedures.
Material & Technical Standards
Rigorous Quality Assurance & Biocompatibility
Every spine implant produced by Orthi Medical Co., Ltd. adheres strictly to international material standards, ensuring optimum fatigue strength, biomechanical performance, and long-term in-vivo stability.
| Implant Material | Standard Specification | Clinical Application |
|---|---|---|
| Ti-6Al-4V ELI (TC4) | ASTM F136 / ASTM F1472 | Pedicle Screws, Cervical Plates, Mesh Cages |
| Biocompatible PEEK | ASTM F2026 / ISO 10993 | Cervical & Lumbar Interbody Fusion Cages |
| Pure Titanium (TA2 / TA3) | ASTM F67 | Low-load Fixation & Specialized Plates |
| Tantalum Wire | ASTM F560 | Radiopaque Markers for X-ray Placement |
Compliance & Manufacturing Highlights
- 100% Traceability: Raw material heat numbers, CNC machining logs, and inspection certificates attached to every batch.
- Cleanroom Packaging: Manufactured in Class 100,000 cleanrooms; available pre-sterilized by Co-60 Gamma Irradiation (SAL 10-6).
- Regulatory Dossiers: Full technical documentation provided for CE and national medical device registrations.
OEM & ODM Manufacturing
Custom Spine Implant & Instrument Manufacturing Solutions
In addition to standard product lines, Orthi Medical Co., Ltd. offers full-service contract manufacturing for global orthopedic brands, providing drawing-based machining, color anodizing, and custom kit assembly.
1. Drawing-Based Precision Machining
5-axis CNC machining of complex titanium pedicle screw threads and PEEK interbody geometries with micro-level tolerances.
2. Anodization & Laser Marking
Color-coded anodization for instant intraoperative size recognition and high-precision laser marking for UDI tracking.
3. Custom Tray & Packaging Design
Ergonomic, sterilizable aluminum instrument trays customized to match specific surgical preferences and private-label packaging.
Procurement FAQ
Frequently Asked Questions for Spine Implant Distributors
Key information regarding minimum order quantities, regulatory compliance, and private label ordering for international buyers.
What certifications do Orthi Medical spine implants carry?
Orthi Medical Co., Ltd. operates under ISO 13485 and ISO 9001 quality management systems. Applicable spine implants and instrument sets carry CE marking and come with complete raw material mill certificates.
Can spine implants be ordered with OEM / private label branding?
Yes. We specialize in OEM and private label partnerships. Services include custom laser marking of your brand logo, custom anodization, localized packaging, and custom instrument tray fabrication.
Are surgical instrument sets included with pedicle screw or cage orders?
We supply full matching surgical instrument sets for all spine systems (Thoracolumbar pedicle screws, PEEK cages, anterior cervical plates, and kyphoplasty systems) organized in heavy-duty sterilizable aluminum trays.
What is the lead time for global shipments?
Standard catalog items are available for rapid dispatch. Custom OEM production runs typically require 4–6 weeks depending on product complexity, machining volume, and packaging requirements.
Partner with a Leading Spine Implant Manufacturer
Send your procurement requirements or OEM technical drawings to [email protected] for a competitive quotation within 24 hours.