5.5 Titanium Alloy Monoaxial Pedicle Screw
Designed for rigid thoracolumbar reconstruction and trauma fixation, featuring optimized thread pitch and dual-lead threads for fast insertion.
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Thoracolumbar & Cervical Spine Implants
Orthomanufacturer Medical Co., Ltd supplies biologically compatible, high-fatigue-strength spinal fixation implants and interbody fusion devices produced under ISO 13485 quality management systems.
4.5 Plus CoCrMo Spinal Fixation System
High-strength Cobalt-Chromium-Molybdenum pedicle screws ideal for complex deformity corrections requiring enhanced rod stiffness.
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Posterior Cervical Laminoplasty System
Low-profile titanium mini plates and screws providing secure fixation following canal decompression for cervical spondylotic myelopathy.
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Titanium Coating Fusion PLIF Cage
Hybrid PEEK interbody cage featuring plasma-sprayed titanium coating to enhance osseointegration while maintaining radiolucency.
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PLIF PEEK Cage
Anatomically contoured lumbar interbody spacer with tantalum markers for radiopaque positioning during posterior lumbar interbody fusion.
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Cervical Expandable Titanium Cage
Continuous expansion mechanism allowing precise intraoperative height adjustment to restore cervical lordosis and disc height.
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Cervical Titanium Mesh
Corpectomy cage system manufactured from pure titanium for structural vertebral body replacement following corpectomy procedures.
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Cervical Fusion Cage
Anterior cervical interbody cage with tooth patterns designed to prevent migration and maximize graft contact area.
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Cervical Cannulated Screw
Precision-ground cannulated screws for minimally invasive posterior cervical screw fixation over guide wires.
View Specification Biomechanical Quality
Raw Material & Testing Compliance
Every spine implant produced by Orthomanufacturer Medical Co., Ltd undergoes mechanical testing standard compliance to ensure long-term clinical safety and fatigue resistance.
| Implant Material | Standard Compliance | Mechanical Testing Standard | Clinical Benefit |
|---|---|---|---|
| Ti-6Al-4V ELI Titanium Alloy | ASTM F136 ISO 5832-3 | ASTM F1717 (Static/Dynamic Pedicle Screw) | High strength-to-weight ratio, superior fatigue resistance, MRI compatible. |
| PEEK-OPTIMA Polymer | ASTM F2026 | ASTM F2077 (Interbody Fusion Devices) | Modulus of elasticity matching human cancellous bone to prevent subsidence. |
| CoCrMo High-Strength Alloy | ASTM F1537 ISO 5832-12 | ASTM F1717 (Construct Rigidity) | Superior bending stiffness for severe scoliosis and spinal deformity correction. |
| Commercially Pure Titanium | ASTM F67 ISO 5832-2 | ISO 14577 (Surface Microhardness) | Optimal ductility for intraoperative contouring of laminoplasty and cervical plates. |
Material test reports (MTR) and certificate of analysis (COA) are provided for every production batch shipped to international distributors.
Manufacturing Expertise
OEM & Private-Label Spine Manufacturing
How Orthomanufacturer Medical Co., Ltd supports international orthopedic brands from engineering drawings to regulatory dossier submission.
5-Axis CNC Machining
Swiss-type multi-axis turning lathes manufacture complex pedicle screw thread profiles with tight dimensional tolerances (±0.005mm).
Cleanroom Packaging
Class 100,000 cleanroom cleaning, double-blister sterile packaging, and ethylene oxide (EO) or gamma sterilization integration.
Regulatory Technical Files
Comprehensive technical documentation including STED files, biocompatibility reports, and validation data for local registration.
100% Lot Traceability
High-resolution fiber laser marking on every implant SKU ensures complete traceability back to the raw bar stock heat number.
Distributor FAQ
Frequently Asked Questions
Which implant-grade materials are used for your spine systems?
We utilize Ti-6Al-4V ELI (ASTM F136 / ISO 5832-3), PEEK-OPTIMA (ASTM F2026), CoCrMo alloy (ASTM F1537), and Commercially Pure Titanium (ASTM F67) according to surgical biomechanical demands.
Can Orthomanufacturer Medical support custom private-label spine implant manufacturing?
Yes, Orthomanufacturer Medical Co., Ltd provides complete OEM and ODM manufacturing services, including custom thread geometry, laser marking, anodized color coding, and private-label packaging.
What quality management certifications do your spine production facilities hold?
Our facilities operate under ISO 13485 quality management standards for medical devices, with products compliant with CE documentation requirements to support regulatory clearance across international markets.
Do you supply matched surgical instrument sets for your spine implants?
Yes, every spine implant family is supported by dedicated reusable instrument sets, including pedicle screw drivers, taps, rod benders, trial spacers, and autoclavable container trays.
Global Business Contact
Request Spine Implant Specifications & Quotation
Partner with Orthomanufacturer Medical Co., Ltd for certified spinal implant supply, sample evaluation, and OEM technical support for tender bidding.
- Direct manufacturer pricing & flexible minimum order quantities
- Comprehensive technical dossiers & material test reports
- Dedicated export team support for international registration
Inquire for Distribution
Connect with our orthopedic engineers and export division.
Email Inquiry[email protected]
- Spine implant system specifications
- Distribution market regulatory needs
- OEM / ODM program evaluation