FDA.reportPublic FDA data

SpinMedix® Absorbable Fibrous Membrane

Primary DI
06975222391080
Brand
SpinMedix® Absorbable Fibrous Membrane
Company
Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.
Model
ZK-009
Published
2025-05-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FTLMesh, Surgical, Polymeric
OWWMesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTLMesh, Surgical, PolymericGeneral, Plastic Surgery2
OWWMesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of TendonGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222220000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222220000SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,2023-07-06OWW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975222391080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975222391080069752223910806975222391080

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbableAn implantable material (e.g., flat sheet) made from a bioabsorbable synthetic polymer(s) [e.g., polyglycolic acid (PGA), polycarbonate (PC), polyglycolide or carbon fibres] 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
702939498
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975222391004SpinMedix® Absorbable Fibrous MembraneZK-0012025-05-20
06975222391011SpinMedix® Absorbable Fibrous MembraneZK-0022025-05-20
06975222391028SpinMedix® Absorbable Fibrous MembraneZK-0032025-05-20
06975222391035SpinMedix® Absorbable Fibrous MembraneZK-0042025-05-20
06975222391042SpinMedix® Absorbable Fibrous MembraneZK-0052025-05-20
06975222391059SpinMedix® Absorbable Fibrous MembraneZK-0062025-05-20
06975222391066SpinMedix® Absorbable Fibrous MembraneZK-0072025-05-20
06975222391073SpinMedix® Absorbable Fibrous MembraneZK-0082025-05-20
06975222391097SpinMedix® Absorbable Fibrous MembraneZK-0102025-05-20
06975222391103SpinMedix® Absorbable Fibrous MembraneZK-0112025-05-20
06975222391110SpinMedix® Absorbable Fibrous MembraneZK-0122025-05-20
06975222391127SpinMedix® Absorbable Fibrous MembraneZK-0132025-05-20
06975222391134SpinMedix® Absorbable Fibrous MembraneZK-0142025-05-20
06975222391141SpinMedix® Absorbable Fibrous MembraneZK-0152025-05-20
06975222391158SpinMedix® Absorbable Fibrous MembraneZK-0162025-05-20
06975222391165SpinMedix® Absorbable Fibrous MembraneZK-0172025-05-20
06975222391172SpinMedix® Absorbable Fibrous MembraneZK-0182025-05-20
06975222391189SpinMedix® Absorbable Fibrous MembraneZK-0192025-05-20
06975222391196SpinMedix® Absorbable Fibrous MembraneZK-0202025-05-20
06975222390007Rebuilder Nerve Guidance ConduitTG-0152025-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09421907331874OviTex® CoreAROA BIOSURGERY LIMITEDFTL2025-11-26
09421907331928OviTex® CoreAROA BIOSURGERY LIMITEDFTL2025-11-26
09421907331966OviTex® 1SAROA BIOSURGERY LIMITEDFTL2025-11-26
09421907331997OviTex® 1SAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222072OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222089OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222119OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222126OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222140OviTex® InguinalAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222263OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
10884521857179ParieteneSOFRADIM PRODUCTIONFTL2025-11-08
10653405990123BioBraceConmed CorporationOWW2024-09-20
10653405990130BioBraceConmed CorporationOWW2024-09-20
10653405990147BioBraceConmed CorporationOWW2024-09-20
10653405990154BioBraceConmed CorporationOWW2024-09-20
08903837165978Surgical MeshHEALTHIUM MEDTECH LIMITEDFTL2023-08-31
09421906661552OviTex® LPRAROA BIOSURGERY LIMITEDFTL2023-06-15
09421906661569OviTex® LPRAROA BIOSURGERY LIMITEDFTL2023-06-15
10705031085978ULTRAPROJohnson & Johnson International Inc.FTL2022-11-08
10705031085985ULTRAPROJohnson & Johnson International Inc.FTL2022-11-08
10607567510996TigerPaw Pro Left Atrial Appendage Closure DeviceDATASCOPE CORP.FTL2020-11-18
09421905067539OviTex® LPRAROA BIOSURGERY LIMITEDFTL2020-03-13
10884521784086Parietene DSSOFRADIM PRODUCTIONFTL2020-01-26
10884521784093Parietene DSSOFRADIM PRODUCTIONFTL2020-01-26
10884521784109Parietene DSSOFRADIM PRODUCTIONFTL2020-01-26
10884521784123Parietene DSSOFRADIM PRODUCTIONFTL2020-01-26
09421906017052Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-29
09421905067157Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-14
09421905067645Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-01
09421905067690Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-01