5-Axis CNC & Swiss Machining
Multi-axis turning and high-speed milling equipped with live tooling for complex bone screw threads and tight-tolerance implant geometries.
FDA Registered Facilities
ISO 13485 Certified Quality System
Validated Prototype-to-Production Workflow
Orthopedic OEM Solutions
End-to-End Contract Manufacturing for Musculoskeletal & Spinal Devices
At Greyack medical Co., Ltd, we partner with leading medical OEMs to supply high-precision orthopedic implants, spinal instrumentation, trauma hardware, and complex surgical tools. Operating under strict ISO 13485 quality management systems, our facilities integrate multi-axis CNC machining, Swiss turning, precision grinding, and additive manufacturing to meet exact customer specifications.
Our technical team delivers Design for Manufacturability (DFM) support during early-stage prototyping, ensuring smooth transitions into full-scale production while supporting rigid process validation (IQ/OQ/PQ) and full lot traceability for regulatory DHF compliance.
Spine & Interbody Systems
Pedicle screws, spinal rods, cross-connectors, cervical plates, and PEEK/titanium interbody cages machined to micron tolerances.
Trauma & Fixation Hardware
Cannulated bone screws, locking plates, intramedullary nails, and anatomical fixation implants.
Surgical Instrumentation
Custom drill guides, reamers, trial implants, taps, inserters, and ergonomic silicone-handled surgical tools.
Joint Reconstruction Devices
Hip stems, acetabular cups, knee femoral components, tibial trays, and shoulder prosthesis implants.
Manufacturing Expertise
Advanced Precision Disciplines for Critical Device Requirements
Greyack medical Co., Ltd combines high-precision machining operations with automated finishing to streamline supply chains and reduce handoff risks.
Precision Medical Grinding
CNC flute, profile, thread, and drill-point grinding for stainless steel orthopedic drills, taps, reamers, and burs.
Metal Additive Manufacturing
Direct metal laser sintering (DMLS) for porous titanium surfaces, lattice structures, and patient-matched surgical guides.
Surface Finishing & Passivation
In-house validated surface treatments including citric and nitric passivation, electropolishing, laser marking, and cleanroom readiness.
Titanium Alloys
Ti-6Al-4V Grade 5 & Grade 23 (ELI) chosen for outstanding fatigue strength, biocompatibility, and bone interface integration.
Cobalt-Chrome (CoCrMo)
ASTM F75 and ASTM F1537 alloys providing extreme wear resistance for load-bearing knee and hip implants.
Medical Stainless Steels
17-4 PH, 316L, Custom 455, and 420 stainless steel varieties machined for high-strength surgical instruments.
Engineered Polymers
Implantable PEEK and PPSU (Radel) machined for radiolucent spinal interbody implants and surgeon trial sets.
Quality Assurance & Compliance
Rigorous Inspection for Regulatory Design History Files (DHF)
Every orthopedic component manufactured by Greyack medical Co., Ltd undergoes rigid dimensional inspection and quality verification under our ISO 13485 Quality Management System. We provide complete documentation to support international regulatory submissions.
- Full material test reports (MTR) & melt source lot traceability
- First Article Inspection Reports (FAIR) per ISO / AS standards
- CMM, optical comparator, and laser profile scanning data
- Validated cleaning and passivation reports (ASTM F86 / ASTM A967)
- Complete lot traceability records ready for supplier qualification audits
OEM Collaboration Workflow
From Blueprint Review to Validated Production
A transparent, risk-mitigated supply model designed for international procurement and engineering teams.
DFM Engineering
Engineers evaluate drawings, geometric tolerances, and material choices to optimize manufacturability.
Rapid Prototyping
Quick-turn machined or 3D-printed prototypes delivered for design verification and clinical evaluation.
Process Validation
IQ/OQ/PQ protocols performed to validate machining, finishing, and cleaning processes under ISO controls.
Scale Production
Multi-axis CNC production, precision grinding, and surface finishing with continuous SPC monitoring.
Packaging & Delivery
Controlled cleanroom cleaning, protective kitting, and consolidated shipping integrated into your global supply chain.
Buyer FAQ
Frequently Asked Questions by OEM Sourcing Teams
What certifications does Greyack medical Co., Ltd hold for orthopedic manufacturing?
Greyack medical Co., Ltd operates FDA-registered manufacturing facilities and maintains an ISO 13485:2016 certified quality management system specifically dedicated to medical device manufacturing. ISO certificates and quality documentation are available upon request during supplier qualification audits.
What types of orthopedic materials do you process?
We work extensively with biocompatible medical-grade materials, including Titanium alloys (Ti-6Al-4V Grade 5 & ELI), Cobalt-Chrome (CoCrMo), Stainless Steels (17-4PH, 316L, 455, Custom 465), Nitinol, and implantable polymers such as PEEK and Radel.
Can you assist with prototype development and short-run production?
Yes. Our dedicated engineering team provides quick-turn prototypes, surgeon-specific custom instruments, and low-volume pre-clinical trial quantities while offering DFM assistance to prepare programs for high-volume commercial manufacturing.
What quality documentation accompanies shipped components?
Each delivery includes comprehensive quality records, such as Certificate of Conformance (CoC), raw material mill test reports, CMM inspection reports, dimensional inspection data, and validated process certificates.
How do international buyers initiate a quote or technical inquiry?
International OEMs can submit technical drawings, 3D STEP models, material specs, and annual volume estimates directly to [email protected]. Our engineering team conducts a thorough manufacturability evaluation and responds promptly.
Partner with a Certified Orthopedic Contract Manufacturer
Send your drawings and technical specifications directly to our engineers: [email protected]