FDA.reportPublic FDA data

VersaCoat Flowable Hydrogel

Primary DI
B454VTP12G10
Brand
VersaCoat Flowable Hydrogel
Company
Alafair Biosciences, Inc.
Model
VTP-12G1
Published
2025-12-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JXICuff, Nerve
OWWMesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXICuff, NerveNeurology2
OWWMesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of TendonGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251505000
K251655000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251505000VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)Alafair Biosciences2025-07-22JXI
K251655000VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)Alafair Biosciences2025-07-18OWW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B454VTP12G10PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nerve guide, synthetic polymer, bioabsorbableAn implantable device intended to be used 1) to create a tunnel through which a discontinuous peripheral nerve can regenerate to bridge the proximal and distal nerve ends, 2) to encase a nerve for protection to aid in repair [e.g., to prevent ingrowth of scar tissue], or 3) for capping the end of an amputated nerve to prevent the formation of a neuroma. It is made of bioabsorbable synthetic polymer(s) in the form of a solid tube or a gel which polymerises in situ, and is designed to be chemically degraded and absorbed via natural body processes. It is also known as a nerve sheath, nerve cuff, nerve protector, nerve conduit, nerve wrap, or nerve cap.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
968882709
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B454VTP44G20VersaCoat Flowable HydrogelVTP-44G22025-11-21
B454VSC10VersaWrapVSC-1VSC-12024-06-10
B454VTP12010VersaWrapVTP-1201VTP-12012020-11-01
B454VTP22010VersaWrapVTP-2201VTP-22012016-12-15
B454VTP22011VersaWrap Tendon ProtectorVTP2201VTP22012020-10-23
B454VTP12011VersaWrap Tendon ProtectorVTP1201VTP12012020-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B454VTP44G20VersaCoat Flowable HydrogelAlafair Biosciences, Inc.OWW2025-11-21
B454VTP44G20VersaCoat Flowable HydrogelAlafair Biosciences, Inc.JXI2025-11-21
20653405990700BioBraceConmed CorporationOWW2025-10-28
30653405990707BioBraceConmed CorporationOWW2025-10-28
G517CW2040ConformaWrapBiocircuit Technologies, Inc.JXI2025-09-10
G517CW4080ConformaWrapBiocircuit Technologies, Inc.JXI2025-09-10
00813954027272Arthrex Nerve ConduitCOLLAGEN MATRIX, INC.JXI2025-07-25
00813954027289Arthrex Nerve ConduitCOLLAGEN MATRIX, INC.JXI2025-07-25
00813954027296Arthrex Nerve ConduitCOLLAGEN MATRIX, INC.JXI2025-07-25
00813954027302Arthrex Nerve ConduitCOLLAGEN MATRIX, INC.JXI2025-07-25
00813954027319Arthrex Nerve ConduitCOLLAGEN MATRIX, INC.JXI2025-07-25
00813954027326Arthrex Nerve ConduitCOLLAGEN MATRIX, INC.JXI2025-07-25
00813954027333Arthrex Nerve WrapCOLLAGEN MATRIX, INC.JXI2025-07-25
00813954027340Arthrex Nerve WrapCOLLAGEN MATRIX, INC.JXI2025-07-25
00813954027357Arthrex Nerve WrapCOLLAGEN MATRIX, INC.JXI2025-07-25
00813954027364Arthrex Nerve WrapCOLLAGEN MATRIX, INC.JXI2025-07-25
00813954027371Arthrex Nerve WrapCOLLAGEN MATRIX, INC.JXI2025-07-25
00813954027388Arthrex Nerve WrapCOLLAGEN MATRIX, INC.JXI2025-07-25
06975222390007Rebuilder Nerve Guidance ConduitNingbo Guangyuan Zhixin Biological Technology Co., Ltd.JXI2025-05-20
06975222390014Rebuilder Nerve Guidance ConduitNingbo Guangyuan Zhixin Biological Technology Co., Ltd.JXI2025-05-20
06975222390021Rebuilder Nerve Guidance ConduitNingbo Guangyuan Zhixin Biological Technology Co., Ltd.JXI2025-05-20
06975222390038Rebuilder Nerve Guidance ConduitNingbo Guangyuan Zhixin Biological Technology Co., Ltd.JXI2025-05-20
06975222390045Rebuilder Nerve Guidance ConduitNingbo Guangyuan Zhixin Biological Technology Co., Ltd.JXI2025-05-20
06975222390052Rebuilder Nerve Guidance ConduitNingbo Guangyuan Zhixin Biological Technology Co., Ltd.JXI2025-05-20
06975222390069Rebuilder Nerve Guidance ConduitNingbo Guangyuan Zhixin Biological Technology Co., Ltd.JXI2025-05-20
06975222390076Rebuilder Nerve Guidance ConduitNingbo Guangyuan Zhixin Biological Technology Co., Ltd.JXI2025-05-20
06975222390083Rebuilder Nerve Guidance ConduitNingbo Guangyuan Zhixin Biological Technology Co., Ltd.JXI2025-05-20
06975222390090Rebuilder Nerve Guidance ConduitNingbo Guangyuan Zhixin Biological Technology Co., Ltd.JXI2025-05-20
06975222391004SpinMedix® Absorbable Fibrous MembraneNingbo Guangyuan Zhixin Biological Technology Co., Ltd.OWW2025-05-20
06975222391011SpinMedix® Absorbable Fibrous MembraneNingbo Guangyuan Zhixin Biological Technology Co., Ltd.OWW2025-05-20