FDA.reportPublic FDA data

OviTex® 1S

Primary DI
09421907331935
Brand
OviTex® 1S
Company
AROA BIOSURGERY LIMITED
Model
F10266-0408G
Device description
The OviTex® Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. OviTex Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device remodels and helps regenerate tissue while reinforcing the repair and providing structural support. Reinforced tissue matrices enhance performance while maintaining compatibility with the body. The OviTex Reinforced Tissue Matrix Device is used for hernia repair and abdominal wall reconstruction.
Published
2025-11-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FTLMesh, surgical, polymeric
FTMMesh, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTLMesh, Surgical, PolymericGeneral, Plastic Surgery2
FTMMesh, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250598000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250598000Endoform Reconstructive Template - PLGAAroa Biosurgery , Ltd.2025-06-03FTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09421907331935PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421907331935094219073319359421907331935

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, biologic-polymer compositeA partially-bioabsorbable, implantable material (e.g., flat sheet) made from both a bioabsorbable animal-derived biologic (e.g., porcine collagen) and a non-bioabsorbable synthetic polymer (e.g., polypropylene) intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature in a dry environment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
594540572
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09421908222522Symphony™ Proliferative BioscaffoldCM03HA003R2026-10-20
09421908222553Symphony OPX™ Proliferative BioscaffoldSY02HA003H2026-10-20
09421908222560Symphony OPX™ Proliferative BioscaffoldSY02HA004H2026-10-20
09421908222577Symphony OPX™ Proliferative BioscaffoldSY02HA006L2026-10-20
09421908222584Symphony OPX™ Proliferative BioscaffoldSY02HA012L2026-10-20
09421908222591Symphony OPX™ Proliferative BioscaffoldSY02HA016L2026-10-20
09421908222607Symphony OPX™ Proliferative BioscaffoldSY02HA025L2026-10-20
09421908222614Symphony OPX™ Proliferative BioscaffoldSY02HA050L2026-10-20
09421908222621Symphony OPX™ Proliferative BioscaffoldSY03HA003H2026-10-20
09421908222638Symphony OPX™ Proliferative BioscaffoldSY03HA004H2026-10-20
09421908222645Symphony OPX™ Proliferative BioscaffoldSY03HA006L2026-10-20
09421908222652Symphony OPX™ Proliferative BioscaffoldSY03HA012L2026-10-20
09421908222669Symphony OPX™ Proliferative BioscaffoldSY03HA016L2026-10-20
09421908222676Symphony OPX™ Proliferative BioscaffoldSY03HA025L2026-10-20
09421908222683Symphony OPX™ Proliferative BioscaffoldSY03HA050L2026-10-20
09421908222690Symphony OPX™ Proliferative BioscaffoldSY02HA002H2026-10-20
09421908222706Symphony OPX™ Proliferative BioscaffoldSY03HA002H2026-10-20
09421908222409Myriad Matrix™ Restore Restorative BioscaffoldSR02LG004S2026-01-30
09421908222416Myriad Matrix™ Restore Restorative BioscaffoldSR02LG006R2026-01-30
09421908222423Myriad Matrix™ Restore Restorative BioscaffoldSR02LG012R2026-01-30

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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