Who else makes this device?

Name: T-Line Hernia Mesh
Brand: T-Line Hernia Mesh

General & Plastic Surgery › ProstheticMesh, Surgical, Polymeric

T-Line Hernia Mesh

T-Line Hernia Mesh reinforces weakened soft tissue during ventral hernia repair performed through an open onlay approach. The implant includes mesh extensions that secure the mesh body to…

Registry build 21.09.26

T-Line Hernia Mesh reinforces weakened soft tissue during ventral hernia repair performed through an open onlay approach. The implant includes mesh extensions that secure the mesh body to the abdominal fascia. The extensions are continuous parts of the mesh rather than separately attached components.

Surgeons sew the extensions into fascia using needles swaged onto their ends. The extensions and mesh body are knitted from the same medical-grade polypropylene monofilament yarn, forming an uninterrupted structure between the reinforcement sheet and its fixation extensions.

Listed Item

T-Line Hernia Mesh, 13.5cc x 15.5cm

Mesh Structure

Knitting and heat pressing form the mesh from polypropylene yarn. The mesh has a large-pore structure intended to allow tissue incorporation. The fixation extensions distribute the attachment over a broader surface than a conventional polypropylene suture.

1manufacturer

8catalogue numbers in this listing

4510(k) clearances naming this product code

Who Else Makes It

Registered in Shanghai.

Chinese manufacturers registered for FDA product code FTL
Manufacturer	City	Province	Registered as	Device types
Shanghai Suokang Medical Implants Co., Ltd.	Shang Hai	Shanghai	Manufacturer	2

Record

Regulatory record for T-Line Hernia Mesh
Listed by	Deep Blue Medical Advances, Inc., United States
FDA product code	FTL
Device type	Mesh, Surgical, Polymeric
Device class	Class 2
Regulation	21 CFR 878.3300
Establishment	Specification developer, Manufacturer
510(k)	K193144
Record published	2020-10-30

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for T-Line Hernia Mesh
Catalogue number	Size	Status
TL3020		In distribution
TL1515		In distribution
TL1507		In distribution
TL3007		In distribution
TL1520		In distribution
TL3015		In distribution
TL3010		In distribution
TL1510		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Technical Products	Technical Products, Inc.	143
Parietex	Sofradim Production	82
DynaMesh	FEG Textiltechnik Forschungs- und Entwicklungsges. mbH	45
Symbotex	Sofradim Production	35
Silicone Sheeting Reinforced	Bentec Medical OpCo, LLC.	33
Parietene	Sofradim Production	32
C-QUR	Atrium Medical Corporation	31
ProGrip	Sofradim Production	31
Silicone Sheeting Non-Reinforced	Bentec Medical OpCo, LLC.	31
Prolite	Atrium Medical Corporation	31
Gore Seamguard Bioabsorbable Staple Line Reinforce	W. L. Gore & Associates, Inc.	30
Surgimesh®wn	Aspide Medical	28

Showing 12 of 148. All products under Mesh, Surgical, Polymeric

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K232924	2023-10-18
K230227	2023-02-23
K221556	2022-11-28
K193144	2020-03-30

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number	Decision	Trade name	Approved to
P990028	2003-12-04	FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT	Genzyme Corporation

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.