Pedicle Screw System
Dual-thread design for rapid insertion and purchase in cortical and cancellous bone. Includes monoaxial, polyaxial, and friction-head screws for complex thoracolumbar reconstruction.
Inquire NowSpine System Implants & Surgical Solutions
Precision-engineered pedicle screw systems, PEEK interbody fusion cages, cervical plates, and matched surgical instruments for global medical distributors and OEM partners.
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ASTM F136 Ti-6Al-4V ELI & PEEK standard
0& 6.0
Thoracolumbar rod diameter options (mm)
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Full lot traceability & laser coding
0 ISO
Certified medical device manufacturing
Product Portfolio
Comprehensive Spine Fixation & Fusion Systems
Orthomanufacturer Medical Co., Ltd supplies complete spine portfolios engineered for anatomical precision, construct stability, and smooth intraoperative hand-feel.
Anterior Cervical Plate System
Low-profile locking plate design minimizing esophageal distraction. Features tactile locking mechanisms and pre-contoured anatomical curvature for anterior cervical fusion.
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PEEK Interbody Fusion Cages
Manufactured from implant-grade PEEK polymer (ASTM F2026) with radiopaque tantalum markers. Pyramidal serrations prevent cage migration while optimizing graft area.
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MIS Cannulated Screw System
Percutaneous spine fixation system featuring extended tower screws, K-wire insertion guides, and rod-passing instruments for reduced muscle trauma and faster patient recovery.
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Balloon Kyphoplasty System
Complete single-use kit for vertebral body height restoration in osteoporotic compression fractures, including high-pressure balloons, inflation devices, and access cannulas.
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Spine Surgical Instrument Set
Ergonomic, color-coded stainless steel instrument sets including torque-limiting drivers, rod benders, pedicle awls, taps, and modular sterilization containers.
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Engineering Standards
Spine System Material & Technical Specifications
All implants produced by Orthomanufacturer Medical Co., Ltd undergo rigorous mechanical fatigue testing (ASTM F1717 / ASTM F2077) to ensure long-term implant integrity.
| System Category | Material Standard | Key Dimensions / Sizes | Regulatory / Traceability |
|---|---|---|---|
| Thoracolumbar Screws | ASTM F136 Ti-6Al-4V ELI |
Dia: 4.5mm - 7.5mm | Length: 25mm - 55mm | Laser Lot Marked / ISO 13485 |
| Spinal Rods | ASTM F136 Titanium / CoCr |
Dia: 5.5mm & 6.0mm | Straight & Pre-bent | Static & Dynamic Fatigue Tested |
| Cervical Plates & Screws | ASTM F136 Ti-6Al-4V ELI |
Plate Thickness: 2.0mm - 2.4mm | Screw Dia: 3.5mm/4.0mm | 100% Optical Dimension Verified |
| Interbody Fusion Cages | ASTM F2026 PEEK Optima |
PLIF / TLIF / ALIF / Cervical (Heights: 7mm - 14mm) | Tantalum Markers (ASTM F560) |
| Cross-Link Connectors | ASTM F136 Ti-6Al-4V ELI |
Fixed & Adjustable Lengths (35mm - 65mm) | Dual Locking Set-screw Mechanism |
| Surgical Instruments | Custom AISI 630 / 17-4PH SS |
Modular Handles / Quick-Couple Connectors | Autoclave & Corrosion Tested |
Manufacturing Control
Spine Implant Manufacturing Assurance
From raw bar stock evaluation to final ultrasonic cleaning, our manufacturing processes guarantee bio-compatibility and precision engineering.
01
Material Certification
Strict raw material validation for medical-grade titanium bar stock and PEEK resin according to ISO and ASTM standards.
02
5-Axis CNC Machining
Swiss-type precision machining for intricate pedicle screw threads, self-tapping flutes, and variable polyaxial heads.
03
Surface Anodizing
Type II color anodizing for immediate intraoperative size recognition and enhanced titanium corrosion resistance.
04
100% Optical Inspection
Dimensional verification of critical screw threads and locking taper tolerances using automated CMM inspection systems.
OEM & Private Label
Custom Spine Solutions for Global Distributors
Orthomanufacturer Medical Co., Ltd supports international orthopedic brands with complete turn-key OEM manufacturing, registration dossier assistance, and customized branding.
Private-Label Branding
Custom laser etching of distributor logo, reference code, lot number, and UDI barcode directly on implants and instrument handles.
Custom Instrument Trays
Tailored anodized aluminum sterilization containers designed around your target surgical technique and hospital workflow.
Registration Support
Comprehensive technical dossier preparation (STED format), material certifications, laboratory test reports, and IFUs for rapid local approval.
OEM Custom Engineering
Rapid prototyping from customer drawings or sample evaluation with full support from our dedicated orthopedic engineering team.
FAQ
Frequently Asked Questions on Spine Systems
What spinal implant systems are manufactured by Orthomanufacturer Medical Co., Ltd?
We manufacture comprehensive thoracolumbar pedicle screw systems (monoaxial, polyaxial, cannulated MIS), anterior cervical plate systems, PEEK interbody fusion cages (PLIF, TLIF, ALIF, Cervical), cross-links, and matching ergonomic surgical instrument sets.
Which raw materials are utilized in your spine systems?
All spine implants are produced using implant-grade Titanium Alloy Ti-6Al-4V ELI conforming to ASTM F136 / ISO 5832-3 and radiolucent PEEK polymer conforming to ASTM F2026 with tantalum marker pins for radiographic visualization.
Do you offer OEM private-label branding and custom design for spine projects?
Yes. We support custom laser marking of logo and lot numbers, customized sterilization tray configurations, bespoke packaging design, and OEM engineering modifications according to your technical drawings.
What technical documentation is provided for registration?
We provide ISO 13485 documentation, raw material mill certificates, mechanical fatigue test reports, packaging validation reports, IFUs (Instructions for Use), and full technical files to facilitate distributor regulatory clearance.