Axogen Corp

FDA Filings

This page includes the latest FDA filings for Axogen Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3011006318
• FEI Number: 3011006318
• Name: AxoGen Corporation
• Owner & Operator: AxoGen Corporation
• Contact Address: 13631 Progress Blvd Suite 400; Alachua FL 32615 US
• Official Correspondent:
  • Mark L Friedman
  • x-386-4626800-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 300 Boone Rd Ste A3 ; Burleson, TX 76028 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3006252977
• FEI Number: 3006252977
• Name: AXOGEN CORPORATION
• Owner & Operator: AxoGen Corporation
• Contact Address: 13631 Progress Blvd Suite 400; Alachua FL 32615 US
• Official Correspondent:
  • Mark L Friedman
  • x-386-4626800-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 13631 Progress Blvd Ste 400 ; Alachua, FL 32615 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 10850828007142 AXOGEN CORPORATION	Axoguard HA+ Nerve Protector	2023-05-02
GUDID 10850828007135 AXOGEN CORPORATION	Axoguard HA+ Nerve Protector	2023-05-02
GUDID 10850828007128 AXOGEN CORPORATION	Axoguard HA+ Nerve Protector	2023-05-02
GUDID 10850828007111 AXOGEN CORPORATION	Axoguard HA+ Nerve Protector	2023-05-02
GUDID 10850828007104 AXOGEN CORPORATION	Axoguard HA+ Nerve Protector	2023-05-02
GUDID 00850828007091 AXOGEN CORPORATION	AxoGuard Nerve Cap	2021-04-19
GUDID 00850828007084 AXOGEN CORPORATION	AxoGuard Nerve Cap	2021-04-19
GUDID 00850828007077 AXOGEN CORPORATION	AxoGuard Nerve Cap	2021-04-19
GUDID 00850828007060 AXOGEN CORPORATION	AxoGuard Nerve Cap	2021-04-19
GUDID 00850828007053 AXOGEN CORPORATION	AxoGuard NerveCap	2021-04-19
GUDID 00850828007046 AXOGEN CORPORATION	AxoGuard Nerve Cap	2021-04-19
PMN K163446 AxoGen Corporation	AxoGen Nerve Cap	2017-08-08
PMN K934368 | LLN AxoGen Corporation	Pressure Specified Sensory Device?	2016-02-24
PMN K934368 | LLN AXOGEN CORPORATION	Pressure Specified Sensory Device?	2016-02-24
PMN K923963 | LBB AxoGen Corporation	AcroGrip?	2016-02-24
PMN K923963 | LBB AXOGEN CORPORATION	AcroGrip?	2016-02-24
PMN K914056 | LBB AxoGen Corporation	AcroPinch?	2016-02-24
PMN K914056 | LBB AXOGEN CORPORATION	AcroPinch?	2016-02-24
GWI AxoGen Corporation	AxoTouch	2014-07-18
GWI AXOGEN CORPORATION	AxoTouch	2014-07-18

Related Finance Registrations

NCAGE Code	4BMD7	AXOGEN CORPORATION
CAGE Code	4BMD7	AXOGEN CORPORATION
S.A.M. Registration	4BMD7 [113424464]	AXOGEN CORPORATION
SEC	0001358347	AXOGEN CORP of DELAWARE