Tissue Establishment Registration
The U.S. Food and Drug Administration (FDA).
Transforming Biologics Landscapes Worldwide
We are a rising American provider of innovative allograft and tissue based products.
Company
Enfisa Biologics is a Miami, FL USA based full scale tissue provider which is constantly striving for creative treatment options to progress clinical, surgical, and therapeutic patient care by expanding industry knowledge and capability.
We focus on becoming an innovative partner of choice for quality and customer-focused allograft solutions. We provide top quality allografts for spinal, neuro, trauma, ortho and dental cases in more than 20 countries worldwide.
Enfisa Biologics accomplishes this through sustaining partnership only with the most reputable tissue banks in the USA where all tissues are rigorously screened for standard panel of infectious viruses. All Enfisa Biologics donor tissues are sourced from FDA registered and AATB accredited tissue banks in the United States.
Products
Our extensive range of allografts provide surgeons with the necessary resources they need to improve the lives of patients every single day.
Covering areas such as spine, neurology, trauma, sports medicine, skin, and wound treatments, as well as craniomaxillofacial, general orthopedics, and oncology interventions, our all-encompassing portfolio ensures that surgeons, and subsequently their patients, have access to the most suitable grafts for specific medical procedures.
To obtain detailed information on our allografts, kindly download our catalog.
Quality
We are committed to maintaining the highest standards of quality in every aspect of our operations. Our products undergo rigorous testing and quality control procedures to ensure safety, efficacy, and reliability. We adhere to strict regulatory guidelines and have robust quality management systems in place to consistently deliver biologic solutions of the utmost quality.
Enfisa Biologics management and employees are committed to maintaining a quality assurance program that effectively complies with applicable federal and state regulations; implements industry best-practices and ensures customer requirements are met.
Medical Device Manufacturer Registration
The U.S. Food and Drug Administration (FDA).
ISO 9001
ISO 13485
Certification
Medical Devices Quality Management Systems.
As an ISO 13485 certified manufacturer that has been implementing the paramount level of Quality Management Systems:
At Enfisa Biologics, we strictly adhere to this standard to ensure that our manufacturing processes and quality management systems consistently meet regulatory and customer requirements. Compliance with ISO 13485 demonstrates our commitment to delivering safe and effective solutions to our network of surgeons and distributors which aim nothing but the highest level of patient satisfaction.
Enfisa Biologics only accepts donor tissues sourced from FDA registered and AATB (American Association of Tissue Banks) accredited facilities in the United States. Patient safety is our top priority. Our biologic solutions undergo rigorous screening, testing, and validation to ensure they meet stringent safety standards. We follow industry best practices to minimize any potential risks associated with our products. We prioritize patient safety at every step of the manufacturing and distribution process.
Distribution
Enfisa Biologics Allografts are being distributed in more than 20 countries. Our commitment lies in delivering secure, efficient, and dependable products to healthcare professionals and patients on a global scale. If you are interested in becoming a distributor of Enfisa Biologics, please fill out the following form to send your request, so we can learn more about your company and present possible partnership opportunities in your region.
Countries Expanded
1
Sales WorldWide
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0
M
Grafts Implants
1
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Contact
Please contact us for all your inquiries via phone, email, or by filling out the contact form on our website.
We look forward to hearing from you and providing the very best allograft solutions for all your needs.
Enfisa Biologics
9100 S Dadeland Blvd
Suite 1500
Miami, FL 33156 USA
Write Us
info@enfisabiologics.com
info@enfisabiologics.com
Contact Us
+1 (786) 613-1974
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