axogeninc.comAvance Nerve Graft
Processed nerve allograft
AxoGen Corporation
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011006318 | 3011006318 | AxoGen Corporation | 1 | N | 2026-01-01 | 300 Boone Rd Ste A3 Burleson TX US 76028 |
| 3017860045 | 3017860045 | Axogen Corporation - Tampa Heights | 1 | N | 2026-01-01 | 111 W Oak Ave Suite 500 Tampa FL US 33602 |
| 3006252977 | 3006252977 | AXOGEN CORPORATION | 1 | N | 2020-04-25 | 13631 Progress Blvd Ste 400 Alachua FL US 32615 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 10850828007012 | AcroGrip™ Device - Hand dynamometer intended for use with the AcroVal™ Neurosensory & Motor Testing System (NSMTS) to measure grasp strength. | 888.296.4361 | CustomerCare@AxoGenInc.com |
| 10850828007029 | AcroPinch™ Device - Hand dynamometer intended for use with the AcroVal™ Neurosensory & Motor Testing System (NSMTS) to measure the pinch force of a patient’s fingers. | 888.296.4361 | CustomerCare@AxoGenInc.com |
| 10850828007036 | AxoTouch™ Two-Point Discriminator - The AxoTouch™ Two-Point Discriminator tool is a set of two aluminum discs each containing a series of prongs spaced between 2 to 15 millimeters apart. Additionally, 20 and 25 millimeter spacing is also provided. A circular depression on either side of the disc allows ease of rotation. The discs can be rotated between a single prong for testing one-point and any of the other spaced prongs for testing two-point intervals with ease. Use the AxoTouch™ Two-Point Discriminator tool to measure the innervation density of any surface area of the skin. The discs are useful for measuring sensation after a nerve injury, following the progression of a repaired nerve, and during the evaluation of a person with a possible nerve injury, such as nerve division or nerve compression. | 888.296.4361 | CustomerCare@AxoGenInc.com |
| 10850828007104 | Axoguard HA+ Nerve Protector - Axoguard HA+ Nerve Protector is a surgical implant that provides non-constricting protection for non-transected peripheral nerve injuries. Axoguard HA+ Nerve Protector is designed to be an interface between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is comprised of an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, Axoguard HA+ Nerve Protector is easy to handle, soft, pliable, nonfriable, and porous. The lubricant coating on Axoguard HA+ Nerve Protector is composed of sodium hyaluronate and sodium alginate. When hydrated, the lubricant coating reduces friction between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is flexible to accommodate movement of the joint and associated tendons and has sufficient mechanical strength to hold sutures. Axoguard HA+ Nerve Protector is provided sterile, for single use only, and in a variety of sizes to meet the surgeon’s needs. | 8882964361 | customercare@axogeninc.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 173204 | 1765798369 | K934368 | NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001 | LLN | 1994-08-11 |
| 191794 | 1765798369 | K934368 | NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001 | LLN | 1994-08-11 |
| 173204 | 2035005759 | K923963 | NK DIGI-GRIP SENSOR, MODEL DGR001 | LBB | 1993-03-31 |
| 191794 | 2035005759 | K923963 | NK DIGI-GRIP SENSOR, MODEL DGR001 | LBB | 1993-03-31 |
| 173204 | 1585761085 | K914056 | NK PINCH SENSOR, MODEL PF002 | LBB | 1991-12-09 |
| 191794 | 1585761085 | K914056 | NK PINCH SENSOR, MODEL PF002 | LBB | 1991-12-09 |
| 173204 | 1079956438 | K231708 | Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48) | JXI | 2023-10-12 |
| 285860 | 1079956438 | K231708 | Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48) | JXI | 2023-10-12 |
| 173204 | 1366151175 | K163446 | AxoGen Nerve Cap | JXI | 2017-08-08 |
| 191794 | 1366151175 | K163446 | AxoGen Nerve Cap | JXI | 2017-08-08 |
| 285860 | 1366151175 | K163446 | AxoGen Nerve Cap | JXI | 2017-08-08 |
| 173204 | 1241461127 | ||||
| 191794 | 1241461127 |
Product Codes Associated With Registrations#
NDC#
Avance Nerve Graft
Processed nerve allograft
Avance Nerve Graft
Processed nerve allograft
Avance Nerve Graft
Processed nerve allograft
Avance Nerve Graft
Processed nerve allograft
Avance Nerve Graft
Processed nerve allograft
Avance Nerve Graft
Processed nerve allograft
Avance Nerve Graft
Processed nerve allograft
Avance Nerve Graft
Processed nerve allograft
Avance Nerve Graft
Processed nerve allograft
Avance Nerve Graft
Processed nerve allograft
Avance Nerve Graft
Processed nerve allograft
Avance Nerve Graft
Processed nerve allograft
Avance Nerve Graft
Processed nerve allograft
Avance Nerve Graft
Processed nerve allograft
Avance Nerve Graft
Processed nerve allograft
PMN#
Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)
Axogen Corporation
Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)
Axogen Corporation
AxoGen Nerve Cap
AxoGen Corporation
GUDID#
AcroGrip™ Device - Hand dynamometer intended for use with the AcroVal™ Neurosensory & Motor Testing System (NSMTS) to measure grasp strength.
2017-05-15
AcroPinch™ Device - Hand dynamometer intended for use with the AcroVal™ Neurosensory & Motor Testing System (NSMTS) to measure the pinch force of a patient’s fingers.
2017-05-15
AxoTouch™ Two-Point Discriminator - The AxoTouch™ Two-Point Discriminator tool is a set of two aluminum discs each containing a series of prongs spaced between 2 to 15 millimeters apart. Additionally, 20 and 25 millimeter spacing is also provided. A circular depression on either side of the disc allows ease of rotation. The discs can be rotated between a single prong for testing one-point and any of the other spaced prongs for testing two-point intervals with ease. Use the AxoTouch™ Two-Point Discriminator tool to measure the innervation density of any surface area of the skin. The discs are useful for measuring sensation after a nerve injury, following the progression of a repaired nerve, and during the evaluation of a person with a possible nerve injury, such as nerve division or nerve compression.
2017-05-15
Axoguard HA+ Nerve Protector - Axoguard HA+ Nerve Protector is a surgical implant that provides non-constricting protection for non-transected peripheral nerve injuries. Axoguard HA+ Nerve Protector is designed to be an interface between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is comprised of an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, Axoguard HA+ Nerve Protector is easy to handle, soft, pliable, nonfriable, and porous. The lubricant coating on Axoguard HA+ Nerve Protector is composed of sodium hyaluronate and sodium alginate. When hydrated, the lubricant coating reduces friction between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is flexible to accommodate movement of the joint and associated tendons and has sufficient mechanical strength to hold sutures. Axoguard HA+ Nerve Protector is provided sterile, for single use only, and in a variety of sizes to meet the surgeon’s needs.
2023-04-24
Axoguard HA+ Nerve Protector - Axoguard HA+ Nerve Protector is a surgical implant that provides non-constricting protection for non-transected peripheral nerve injuries. Axoguard HA+ Nerve Protector is designed to be an interface between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is comprised of an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, Axoguard HA+ Nerve Protector is easy to handle, soft, pliable, nonfriable, and porous. The lubricant coating on Axoguard HA+ Nerve Protector is composed of sodium hyaluronate and sodium alginate. When hydrated, the lubricant coating reduces friction between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is flexible to accommodate movement of the joint and associated tendons and has sufficient mechanical strength to hold sutures. Axoguard HA+ Nerve Protector is provided sterile, for single use only, and in a variety of sizes to meet the surgeon’s needs.
2023-04-24
Axoguard HA+ Nerve Protector - Axoguard HA+ Nerve Protector is a surgical implant that provides non-constricting protection for non-transected peripheral nerve injuries. Axoguard HA+ Nerve Protector is designed to be an interface between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is comprised of an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, Axoguard HA+ Nerve Protector is easy to handle, soft, pliable, nonfriable, and porous. The lubricant coating on Axoguard HA+ Nerve Protector is composed of sodium hyaluronate and sodium alginate. When hydrated, the lubricant coating reduces friction between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is flexible to accommodate movement of the joint and associated tendons and has sufficient mechanical strength to hold sutures. Axoguard HA+ Nerve Protector is provided sterile, for single use only, and in a variety of sizes to meet the surgeon’s needs.
2023-04-24
Axoguard HA+ Nerve Protector - Axoguard HA+ Nerve Protector is a surgical implant that provides non-constricting protection for non-transected peripheral nerve injuries. Axoguard HA+ Nerve Protector is designed to be an interface between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is comprised of an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, Axoguard HA+ Nerve Protector is easy to handle, soft, pliable, nonfriable, and porous. The lubricant coating on Axoguard HA+ Nerve Protector is composed of sodium hyaluronate and sodium alginate. When hydrated, the lubricant coating reduces friction between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is flexible to accommodate movement of the joint and associated tendons and has sufficient mechanical strength to hold sutures. Axoguard HA+ Nerve Protector is provided sterile, for single use only, and in a variety of sizes to meet the surgeon’s needs.
2023-04-24
Axoguard HA+ Nerve Protector - Axoguard HA+ Nerve Protector is a surgical implant that provides non-constricting protection for non-transected peripheral nerve injuries. Axoguard HA+ Nerve Protector is designed to be an interface between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is comprised of an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, Axoguard HA+ Nerve Protector is easy to handle, soft, pliable, nonfriable, and porous. The lubricant coating on Axoguard HA+ Nerve Protector is composed of sodium hyaluronate and sodium alginate. When hydrated, the lubricant coating reduces friction between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is flexible to accommodate movement of the joint and associated tendons and has sufficient mechanical strength to hold sutures. Axoguard HA+ Nerve Protector is provided sterile, for single use only, and in a variety of sizes to meet the surgeon’s needs.
2023-04-24
AxoGuard Nerve Cap - The AxoGuard® Nerve Cap is a surgical implant that is a tubular device with one open end, one sealed end (cap) and internal channels designed to provide protection for a peripheral nerve end or stump where repair is unattainable or not desired. The device isolates the nerve stump from the surrounding soft tissue bed by pulling the nerve into the tube and suturing the nerve within the cap. The end of the cap has a suturable tab to allow the surgeon to suture the device to surrounding tissue. AxoGuard® Nerve Cap is an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, AxoGuard® Nerve Cap is easy to handle, soft, pliable, nonfriable and porous. AxoGuard® Nerve Cap is flexible and pliable to accommodate movement of the joints and surrounding soft tissues and has sufficient mechanical strength to hold appropriately sized non-absorbable suture. AxoGuard® Nerve Cap is provided sterile, for single use only, and in a variety of sizes to meet clinical needs.
2017-10-24
AxoGuard NerveCap - The AxoGuard® Nerve Cap is a surgical implant that is a tubular device with one open end, one sealed end (cap) and internal channels designed to provide protection for a peripheral nerve end or stump where repair is unattainable or not desired. The device isolates the nerve stump from the surrounding soft tissue bed by pulling the nerve into the tube and suturing the nerve within the cap. The end of the cap has a suturable tab to allow the surgeon to suture the device to surrounding tissue. AxoGuard® Nerve Cap is an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, AxoGuard® Nerve Cap is easy to handle, soft, pliable, nonfriable and porous. AxoGuard® Nerve Cap is flexible and pliable to accommodate movement of the joints and surrounding soft tissues and has sufficient mechanical strength to hold appropriately sized non-absorbable suture. AxoGuard® Nerve Cap is provided sterile, for single use only, and in a variety of sizes to meet clinical needs.
2017-10-24
AxoGuard Nerve Cap - The AxoGuard® Nerve Cap is a surgical implant that is a tubular device with one open end, one sealed end (cap) and internal channels designed to provide protection for a peripheral nerve end or stump where repair is unattainable or not desired. The device isolates the nerve stump from the surrounding soft tissue bed by pulling the nerve into the tube and suturing the nerve within the cap. The end of the cap has a suturable tab to allow the surgeon to suture the device to surrounding tissue. AxoGuard® Nerve Cap is an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, AxoGuard® Nerve Cap is easy to handle, soft, pliable, nonfriable and porous. AxoGuard® Nerve Cap is flexible and pliable to accommodate movement of the joints and surrounding soft tissues and has sufficient mechanical strength to hold appropriately sized non-absorbable suture. AxoGuard® Nerve Cap is provided sterile, for single use only, and in a variety of sizes to meet clinical needs.
2017-10-24
AxoGuard Nerve Cap - The AxoGuard® Nerve Cap is a surgical implant that is a tubular device with one open end, one sealed end (cap) and internal channels designed to provide protection for a peripheral nerve end or stump where repair is unattainable or not desired. The device isolates the nerve stump from the surrounding soft tissue bed by pulling the nerve into the tube and suturing the nerve within the cap. The end of the cap has a suturable tab to allow the surgeon to suture the device to surrounding tissue. AxoGuard® Nerve Cap is an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, AxoGuard® Nerve Cap is easy to handle, soft, pliable, nonfriable and porous. AxoGuard® Nerve Cap is flexible and pliable to accommodate movement of the joints and surrounding soft tissues and has sufficient mechanical strength to hold appropriately sized non-absorbable suture. AxoGuard® Nerve Cap is provided sterile, for single use only, and in a variety of sizes to meet clinical needs.
2017-10-24
AxoGuard Nerve Cap - The AxoGuard® Nerve Cap is a surgical implant that is a tubular device with one open end, one sealed end (cap) and internal channels designed to provide protection for a peripheral nerve end or stump where repair is unattainable or not desired. The device isolates the nerve stump from the surrounding soft tissue bed by pulling the nerve into the tube and suturing the nerve within the cap. The end of the cap has a suturable tab to allow the surgeon to suture the device to surrounding tissue. AxoGuard® Nerve Cap is an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, AxoGuard® Nerve Cap is easy to handle, soft, pliable, nonfriable and porous. AxoGuard® Nerve Cap is flexible and pliable to accommodate movement of the joints and surrounding soft tissues and has sufficient mechanical strength to hold appropriately sized non-absorbable suture. AxoGuard® Nerve Cap is provided sterile, for single use only, and in a variety of sizes to meet clinical needs.
2017-10-24
AxoGuard Nerve Cap - The AxoGuard® Nerve Cap is a surgical implant that is a tubular device with one open end, one sealed end (cap) and internal channels designed to provide protection for a peripheral nerve end or stump where repair is unattainable or not desired. The device isolates the nerve stump from the surrounding soft tissue bed by pulling the nerve into the tube and suturing the nerve within the cap. The end of the cap has a suturable tab to allow the surgeon to suture the device to surrounding tissue. AxoGuard® Nerve Cap is an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, AxoGuard® Nerve Cap is easy to handle, soft, pliable, nonfriable and porous. AxoGuard® Nerve Cap is flexible and pliable to accommodate movement of the joints and surrounding soft tissues and has sufficient mechanical strength to hold appropriately sized non-absorbable suture. AxoGuard® Nerve Cap is provided sterile, for single use only, and in a variety of sizes to meet clinical needs.
2017-10-24