FDA.reportPublic FDA data

TeKBrace solo

Primary DI
00810198920192
Brand
TeKBrace solo
Company
TheraMicro, LLC
Model
2510S018
Device description
TeKBrace Achilles duo Kit
Published
2026-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QUWMesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QUWMesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of LigamentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K261621000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K261621000TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro2026-06-09QUW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810198920192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810198920192008101989201928101989201920810198920192

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, non-bioabsorbable, multifilament, non-antimicrobialA 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.

Regulatory Flags#

DUNS number
133029114
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810198920345General Instruments2509DK502026-08-18
00810198920352TeKForce2471K0122026-08-18
00810198920376TeKForce2514K0012026-08-18
00810198920178TeKBrace2509K0322026-08-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060267134561FORCECORD ImplantXIROS LTDQUW2026-07-06
00810198920130TekBrace SoloTheraMicro, LLCQUW2026-04-17
05060267134516FORCEWEB 5 mm x 500 mmXIROS LTDQUW2025-11-19
00810198920055TekBrace SoloTheraMicro, LLCQUW2025-08-29
00810198920062TekBrace SoloTheraMicro, LLCQUW2025-08-29
05060267134271SIC GraftXIROS LTDQUW2025-08-07
05060267134493Infinity-Lock 3XIROS LTDQUW2025-08-07
05060267134509Infinity-Lock 5XIROS LTDQUW2025-08-07
05060267134301AchilloCordPLUSXIROS LTDQUW2025-03-26
05060267134295Poly-Tape 5 mm x 500 mmXIROS LTDQUW2024-10-10
05060267131812Poly-Tape 30mm x 800mmXIROS LTDQUW2023-07-03
05060267132499Poly-Tape 5 mm x 800 mm XIROS LTDQUW2022-10-14
05060267132505Poly-Tape 7 mm x 800 mm XIROS LTDQUW2022-10-14
05060267132512Poly-Tape 10 mm x 800 mm XIROS LTDQUW2022-10-14
05060267132529Poly-Tape 15 mm x 800 mm XIROS LTDQUW2022-10-14
05060267132536Poly-Tape 20 mm x 800 mm XIROS LTDQUW2022-10-14
05060267132543Infinity-Lock 3XIROS LTDQUW2022-10-14
05060267132550Infinity-Lock 5XIROS LTDQUW2022-10-14
05060267132567Infinity-Lock 7 XIROS LTDQUW2022-10-14