FDA.reportPublic FDA data

TekBrace Solo

Primary DI
00810198920055
Brand
TekBrace Solo
Company
TheraMicro, LLC
Model
2470S012
Device description
Soft Tissue Reinforcement Device - 12cm
Published
2025-08-29
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
OWXMesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
QUWMesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTLMesh, Surgical, PolymericGeneral, Plastic Surgery2
OWXMesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of TendonGeneral, Plastic Surgery2
QUWMesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of LigamentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251063000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251063000TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro2025-05-30QUW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810198920055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810198920055008101989200558101989200550810198920055

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, non-bioabsorbable, multifilamentA multiple-strand (multifilament), synthetic thread made from a non-bioabsorbable polyester intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
133029114
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810198920086TekBrace2470K0122026-04-17
00810198920093TekBrace2470K0252026-04-17
00810198920109TekBrace2508K0082026-04-17
00810198920116TekBrace2470E3902026-04-17
00810198920123TekBrace2470E4752026-04-17
00810198920130TekBrace Solo2508S0082026-04-17
00810198920147TekBrace2470A3902026-04-17
00810198920154TekBrace2470A4752026-04-17
00810198920161TekBrace2470A5502026-04-17
00810198920222TekBrace2470K2122026-04-17
00810198920239TekBrace2470K2252026-04-17
00810198920246TekBrace2513K1252026-04-17
00810198920253TekBrace2509K0252026-04-17
00810198920260TekBrace2470E5502026-04-17
00810198920307TeKForce2471A0122026-04-17
00810198920314TeKForce2471A0152026-04-17
00810198920321TeKForce2471A1152026-04-17
00810198920338TeKForce2514S0012026-04-17
00810198920062TekBrace Solo2470S0252025-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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
09421905067706Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-01
09421905067713Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-01
09421905067720Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-01
09421905067751Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-01