FDA.reportPublic FDA data

X-RepairSL

Primary DI
B05502020
Brand
X-RepairSL
Company
SYNTHASOME, INC.
Model
Z020-20SL
Catalog number
Z020-20SL
Device description
X-RepairSL, Bioabsorbable surgical mesh, single-layer 4mm x 20mm (WxL)
Published
2023-07-24
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
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
K141499000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141499000X-REPAIRSLSynthasome, Inc.2014-07-02FTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B05502020PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length20Millimeter
Width4Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
858-490-9400info@synthasome.com

Regulatory Flags#

DUNS number
140697280
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B055008X-RepairZ008Z0082023-07-24
B05500925X-RepairZ009-25Z009-252023-07-24
B05500935X-RepairZ009-35Z009-352023-07-24
B055010X-RepairZ010Z0102023-07-24
B05501030X-RepairZ010-30Z010-302023-07-24
B05501035X-RepairZ010-35Z010-352023-07-24
B05502080X-RepairSLZ020-80SLZ020-80SL2023-07-24
B05502120X-RepairSLZ021-20SLZ021-20SL2023-07-24
B05502180X-RepairSLZ021-80SLZ021-80SL2023-07-24
B055009X-RepairZ009Z0092016-10-03
B05500930X-RepairZ009-30Z009-302016-01-05
B055020160SLX-RepairSLZ020-160SLZ020-160SL2017-02-13
B055021160SLX-RepairSLZ021-160SLZ021-160SL2017-02-13
B05502280SLX-RepairSLZ022-80SL2017-02-13
B05502480SLX-RepairSLZ024-80SLZ024-80SL2017-02-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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09421908222119OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222126OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
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09421908222263OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
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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
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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
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09421905067645Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-01
09421905067690Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-01