Question 1

Are Prodorth spinal implants CE certified?

Accepted Answer

Yes. All Prodorth products are CE certified and manufactured in compliance with international medical device regulations and quality standards.

Question 2

Are Prodorth spinal implants safe?

Accepted Answer

Prodorth spinal implants are designed and manufactured in compliance with international safety and quality standards. All implants hold CE certification and undergo rigorous biocompatibility and biomechanical testing. Based on available data, no serious adverse events have been reported.

Question 3

Do Prodorth implants undergo biocompatibility and biomechanical testing?

Accepted Answer

Yes. All Prodorth implants are tested according to internationally recognized standards. Biocompatibility testing is conducted in accordance with ISO 10993, and biomechanical testing is performed to verify implant performance, safety, and reliability.

Question 4

What materials are used in Prodorth spinal implants and surgical instruments?

Accepted Answer

Prodorth implants are manufactured using medical-grade titanium (Ti6Al4V-ELI – Grade 23, ASTM F136) and PEEK (ASTM F2026). Surgical instruments are produced from high-quality stainless steel to ensure durability and precision.

Question 5

Are Prodorth implants and instruments manufactured in-house?

Accepted Answer

Yes. All Prodorth implants and surgical instruments are manufactured in-house under strict quality control processes to ensure consistent precision, reliability, and production standards.

Question 6

Does Prodorth provide sterile spinal implants?

Accepted Answer

Currently, Prodorth products are not supplied in sterile packaging. However, the company is in the process of transitioning to sterile packaging solutions and plans to complete this transition by the end of the year.

Question 7

How long can Prodorth surgical instruments be reused?

Accepted Answer

Prodorth surgical instruments are designed for long-term use when proper maintenance and sterilization procedures are followed. The actual lifespan depends on usage frequency and sterilization conditions. Regular inspections are recommended to maintain safe clinical use.

Frequently Asked Questions (FAQ)