FDA.reportPublic FDA data

BioBridge® Collagen Matrix

Primary DI
B218PRT0070
Brand
BioBridge® Collagen Matrix
Company
Fibralign Corporation
Model
PRT0070
Catalog number
PRT0070
Device description
The Fibralign BioBridge® Collagen Matrix is a sterile, thin collagen ribbon made of highly purified pepsin treated Type 1 porcine collagen and features Fibralign’s Nanoweave® technology. It is provided in single use packaging with five devices included in each package.
Published
2020-12-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of TendonGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151083000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151083000BioBridge Collagen MatrixFibralign Corporation2016-01-08OWY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B218PRT00700PackageHIBCC1In Commercial Distribution
B218PRT0070PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical mesh, collagen, bioabsorbableA sterile, bioabsorbable, flat or three-dimensional (3-D) implantable material made from animal-derived collagen intended for multiple tissue defect repair/hernia reduction (e.g., inguinal, ventral/incisional, umbilical, femoral) applications including an extra-abdominal application(s) [e.g., plastic surgery, breast reconstruction]. It may also be used as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry
Storage Environment Temperature0 Degrees Celsius37 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
415-902-4721info@fibralignbio.com
415-902-4721gking@fibralignbio.com

Regulatory Flags#

DUNS number
023369802
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812337020695Medeor Tendon MatrixDSM BIOMEDICAL, INC.OWY2026-03-24
00812337020701Medeor Tendon MatrixDSM BIOMEDICAL, INC.OWY2026-03-24
00812337020794Meso Tendon MatrixDSM BIOMEDICAL, INC.OWY2026-03-24
00812337020800Meso Tendon MatrixDSM BIOMEDICAL, INC.OWY2026-03-24
00812337020817Meso Tendon MatrixDSM BIOMEDICAL, INC.OWY2026-03-24
00812337020824Meso Tendon MatrixDSM BIOMEDICAL, INC.OWY2026-03-24
05694310966443Kerecis SurgiBind® Tendon ProtectKERECIS hf.OWY2026-02-03
05694310966474Kerecis SurgiBind® Tendon ProtectKERECIS hf.OWY2026-02-03
05694310966467Kerecis SurgiBind® Tendon ProtectKERECIS hf.OWY2026-02-03
05694310966450Kerecis SurgiBind® Tendon ProtectKERECIS hf.OWY2026-02-03
00860011716730B3 GEL SystemTybr Health, Inc.OWY2025-12-17
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00810063820473TAPESTRY Biointegrative Implant with Introducer, w/ CannulaEmbody, Inc.OWY2024-02-09
00810063820480TAPESTRY Biointegrative Implant with Introducer, w/ CannulaEmbody, Inc.OWY2024-02-09