Spinal Internal Fixation System Manufacturer | ISO 13485 Certified Implants

ISO 13485 Certified Medical Grade Standard

Ti6Al4V ELI & PEEK Biocompatible Materials

32+ Countries Exported 365+ Hospitals Trusted

ASTM F1717 / ISO 12189 Fatigue Tested & Verified

Orthopedic Surgical Excellence

Advanced Spinal Internal Fixation Solutions

CareFix® delivers comprehensive, high-precision spinal fixation systems designed for complex spine surgery. Engineered with superior titanium alloys and PEEK biomaterials, our products assure structural stability, early postoperative mobilization, and predictable interbody fusion across thoracolumbar and cervical procedures.

Posterior Spinal Screw-Rod System

Featuring low-profile polyaxial and monoaxial pedicle screws with self-tapping threads for rapid, high-pullout strength fixation in degenerative, traumatic, and scoliosis spinal correction.

Material: Medical Grade Titanium Alloy (Ti-6Al-4V ELI)

Screw Diameter: 4.5mm - 7.5mm | Rod: 5.5mm / 6.0mm

Indication: Spondylolisthesis, Fracture, Degenerative Disc

Anterior Cervical Plate System

Ultra-thin anatomical design providing safe anterior locking mechanisms, tactile screw engagement, and optimal graft visualization during Anterior Cervical Discectomy and Fusion (ACDF).

Profile Thickness: 2.0mm - 2.4mm Low Profile

Configuration: 1-Level to 4-Level Cervical Plates

Indication: Cervical Degenerative Disc, Kyphosis, Trauma

Cervical Interbody Fusion Cage

Constructed from radiolucent PEEK material matching bone elastic modulus. Anatomically contoured serrations prevent cage migration while maximizing graft volume.

Material: Radiopaque PEEK Optima + Tantalum Markers

Lordotic Angle: 0°, 4°, 8° options for lordosis restoration

Indication: ACDF procedures, Cervical Radiculopathy

Thoracolumbar Interbody Fusion Cage

Optimized for PLIF/TLIF minimally invasive approaches. Bullet-shaped nose design allows smooth insertion into tight disc spaces while restoring sagittal balance.

Technique: PLIF / TLIF Surgical Access Compatible

Features: Large Central Bone Graft Chamber & Anti-Backout Teeth

Indication: Lumbar Spondylolisthesis, Disc Degeneration

Laminoplasty Plate Fixation System

Engineered for open-door posterior cervical laminoplasty. Provides rigid, titanium hinge fixation to expand the spinal canal and treat cervical compressive myelopathy.

Design: Low profile hinge plate with bone graft window

Screws: Self-drilling 2.0mm / 2.4mm locking screws

Indication: OPLL, Multilevel Cervical Stenosis

Quality & Engineering Standards

Biomechanical Precision & Rigorous Compliance

CareFix® spinal internal fixation implants are manufactured under strict ISO 13485 quality management systems using state-of-the-art multi-axis CNC Swiss machining centers. Each component undergoes 100% optical dimensional inspection and fatigue strength evaluation matching international ASTM and ISO standards.

Our commitment to material biocompatibility ensures optimal clinical outcomes, zero dynamic fretting corrosion, and accelerated osseointegration across all spinal reconstruction cases.

Parameters	CareFix Technical Specification
Manufacturing Certificate	ISO 13485:2016 Certified Facility
Metals & Materials	Ti-6Al-4V ELI (ASTM F136) / PEEK (ASTM F2026)
Fatigue Testing Standard	ASTM F1717 / ISO 12189 Dynamic Compression
Surface Finish	Type II Anodization & Micro-textured passivation
Cleanroom Packaging	ISO Class 7 Cleanroom Double Blister Packaging
Traceability	Full UDI Laser Marking & Batch Lot Tracking

Why Choose CareFix

Global OEM/ODM & B2B Supply Capabilities

Empowering hospital procurement departments, medical device distributors, and orthopedic surgical teams with dependable quality and scalable supply chains.

Clinical Integrity

Designed in close partnership with senior orthopedic spine surgeons, ensuring ergonomic instrument design and minimal operative friction during pedicle screw placement.

Dedicated Instrument Trays

Each spinal internal fixation system is accompanied by ergonomic, high-durability sterilization trays and specialized surgical instrumentation for smooth intraoperative workflow.

Global Regulatory Support

Complete technical documentation, CE/ISO alignment, registration dossiers, and test reports available for fast regional market clearance and tender bidding.

Request Technical Specifications & Global Wholesale Pricing

Partner with a trusted ISO 13485 certified manufacturer. Contact our orthopedic product specialists today for sample kits, surgical catalogs, and distributor pricing terms.

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