registration and licences

Axogen documents

Registration and licenses

This document is for regulatory and compliance purposes only and does not imply product efficacy or endorsement.

• Association for Advancing Tissue and Biologics certificate of accreditation – AATB

These tissue establishment registrations are for regulatory compliance purposes and do not imply FDA approval of the safety or efficacy of Axogen’s products.

• Axogen Tissue Establishment Registration – Florida (FDA regulatory compliance document)
• Axogen Tissue Establishment Registration – Dayton, Ohio (FDA regulatory compliance document)
• Axogen Tissue Establishment Registration – Vandalia, Ohio (FDA regulatory compliance document)
• Axogen Tissue Establishment Registration – Texas (FDA regulatory compliance document)

Axoguard^® family of products

Registration, licenses and IFUs

• Axogen Canadian medical device license establishment
• Axogen ISO 13485 registration

This document represents the 510(k) clearance letter for regulatory compliance and does not imply FDA endorsement or approval of the product’s safety or efficacy.

• Cook Biotech 510(k) k132660 clearance letter

This document represents the CE mark certification for regulatory compliance in the European Union.

• Axoguard CE mark
• Cook Biotech device listing – FDA compliance document

This document is for FDA device listing and does not imply FDA endorsement or approval of the product’s safety or efficacy.

• Cook Biotech ISO 13485 registration
• NABP drug distributor accreditation

Intended for healthcare professionals only. Please refer to the full Instructions for Use for complete details.

• Axoguard Nerve Connector IFU

Intended for healthcare professionals only. Please refer to the full Instructions for Use for complete details.

• Axoguard Nerve Protector IFU

Intended for healthcare professionals only. Please refer to the full Instructions for Use for complete details.

• Axoguard HA+ Nerve Protector IFU

Intended for healthcare professionals only. Please refer to the full Instructions for Use for complete details.

• 510(k) Axoguard HA+ Nerve Protector clearance letter

Intended for healthcare professionals only. Please refer to the full Instructions for Use for complete details.

• Axoguard Nerve Cap IFU
• Axogen 510(k) Nerve Cap clearance letter

This document is for FDA device listing and does not imply FDA endorsement or approval of the product’s safety or efficacy.

• Axogen device listing (FDA regulatory compliance document)

Some documents may show expiration dates that are not current. This is usually due to delays by the federal, state or private agency responsible for the inspection, application review and issuance of these licenses or certificates. While the listed documents may show expiration dates, they remain valid until the review or renewal process is completed, and no lapses in regulatory compliance should be inferred.