ISO 13485:2016 · Thai FDA · EU MDR · US FDA

Implants cut to one patient's anatomy.

Seven personalized device systems, designed from your CT and virtual surgical plan, manufactured in medical-grade titanium and polymer. Request, plan, book your engineer and track every case in one place.

SPECIMEN MND-001Ti-6Al-4V ELI · ISO 5832-3
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7
Device systems
10–14
Days, case to delivery
5 yr
Record retention
ISO 5832
Titanium certification

Seven device systems

No public pricing · quote by request

From scan to theatre

Typical 10–14 days
  1. 011–2 days

    Planning

    Upload CT/CBCT and models. Optional 30-minute VSP consult with your design engineer.

  2. 02~3 days

    Design

    Patient-specific plates, meshes and guides drawn on your anatomy. You approve the review file.

  3. 03~4 days

    Manufacturing

    Ti-6Al-4V ELI and medical polymers, inspected and released against a traceable record.

  4. 041–2 days

    Delivery

    Delivered or collected with UDI, lot and Certificate of Conformance.

Regulatory markets

Thai FDA, EU MDR 2017/745 and US FDA. Clearance is stated per device on its specification page.

Traceability

Every request creates an auditable RQ record kept for five years, with UDI and lot at release.

Patient data

Imaging and identifiers are handled under PDPA consent, encrypted at rest, and visible only to your team and ours.

One patient. One anatomy. One device.

Ordering opens after OsseoLabs regulatory affairs verifies your medical license — usually the same business day.

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