Custom · Implants

Patient-specific.
FDA-grade.
Implant-quality.

Custom medical implants — orthopedic, dental, spinal, cranial. Titanium Ti-6Al-4V ELI, PEEK-OPTIMA, surgical stainless. ISO 13485-compatible documentation.

Medical Implants Quote Medical fabrication

Ti-6Al-4V ELI PEEK-OPTIMA ISO 13485 docs Patient-specific

01 · Implant categories

What we manufacture.

Custom implants serve patient-specific surgical needs. Material biocompatibility, manufacturing precision, surface quality all matter for implant performance.

02 · Quality requirements

Implant standards.

FAQ

Medical Implants questions.

Customer holds FDA 510(k) clearance for implant product. We manufacture per customer-approved drawings/specs. Customer manages FDA submission.

We use FDA-listed materials with USP Class VI testing where applicable. Material certs accompany each lot. Specific material per implant: PEEK-OPTIMA, Ti-6Al-4V ELI, 316LVM stainless.

From customer CT/MRI imaging (DICOM format) we machine implants matching individual anatomy. CAD model generated, customer reviews, then manufactured.

Final cleaning in ISO 7 cleanroom. Particle-controlled packaging. Sterile-ready (customer sterilizes per validated process).

Patient-specific implants 2-4 weeks from data receipt. Production implants per customer scheduling.

Material certificates, dimensional inspection, lot/serial number, surface finish documentation. Format per customer ISO 13485 requirements.