FDA.reportPublic FDA data

FiberStitch Implant 1.5 Simple Straight RC with two Poly

Primary DI
10810128461105
Brand
FiberStitch Implant 1.5 Simple Straight RC with two Poly
Company
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
Model
C30303-05
Catalog number
176810ar
Published
2026-01-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MBIFastener, Fixation, Nondegradable, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190125000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190125000FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWireT.A.G. Medical Products Corporation, Ltd.2019-05-19MBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810128461105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081012846110510810128461105

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue/mesh anchor, non-bioabsorbableA non-bioabsorbable device designed to be implanted into ligaments or other soft tissues to serve as a site of attachment for surgical binding materials/implants (e.g., mesh, sutures); it is not intended to anchor soft tissues to bone, nor repair cartilage, and is not intended for ophthalmic use. It is typically a threaded screw-like device, and is made of a material that cannot be chemically degraded or absorbed via natural body processes (e.g., metal, polypropylene); it is intended to create a fixed anchor point and is not a suture-based fastening device such as a T-fastener. It is typically implanted with the use of a specialized disposable applicator which may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
534123013
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810128464045VersiTomic 2-Fluted Cannulated Reamer Ø11.0mm234-113-110124110st2026-08-03
10810128463079OSSIO® Threaded Trimmable Fixation Nail Instrument Pack W Drill Bit 7.0x70mmTHN00720134070oss2026-08-23
10810128463086OSSIO® Threaded Trimmable Fixation Nail Instrument Pack W Drill Bit 7.0x100mmTHN00721134100oss2026-08-23
10810128463185OSSIO® Threaded Trimmable Fixation Nail Instrument Pack 7.0x70mmTHN00685134070-01oss2026-08-23
10810128463192OSSIO® Threaded Trimmable Fixation Nail Instrument Pack 7.0x100mmTHN00684134100-01oss2026-08-23
10810128464311Hip 2.5 Grasper393400t393400t2026-03-19
10818674024324Hip Bone Pick 60°512404t512404t2026-03-19
10810128463918VersiTomic RR Retrograde Reamer 4.5 x 10.5mm0234-109-105145105st2026-08-03
10810128463925VersiTomic 2-Fluted Cannulated Reamer Ø5.0mm234-113-050124050st2026-08-03
10810128463932VersiTomic 2-Fluted Cannulated Reamer Ø5.5mm234-113-055124055st2026-08-03
10810128463949VersiTomic 2-Fluted Cannulated Reamer Ø6.0mm234-113-060124060st2026-08-03
10810128463956VersiTomic 2-Fluted Cannulated Reamer Ø6.5mm234-113-065124065st2026-08-03
10810128463963VersiTomic 2-Fluted Cannulated Reamer Ø7.0mm234-113-070124070st2026-08-03
10810128463970VersiTomic 2-Fluted Cannulated Reamer Ø7.5mm234-113-075124075st2026-08-03
10810128463987VersiTomic 2-Fluted Cannulated Reamer Ø8.0mm234-113-080124080st2026-08-03
10810128463994VersiTomic 2-Fluted Cannulated Reamer Ø8.5mm234-113-085124085st2026-08-03
10810128464007VersiTomic 2-Fluted Cannulated Reamer Ø9.0mm234-113-090124090st2026-08-03
10810128464014VersiTomic 2-Fluted Cannulated Reamer Ø9.5mm234-113-095124095st2026-08-03
10810128464021VersiTomic 2-Fluted Cannulated Reamer Ø10.0mm234-113-100124100st2026-08-03
10810128464038VersiTomic 2-Fluted Cannulated Reamer Ø10.5mm234-113-105124105st2026-08-03

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00810198920178TeKBraceTheraMicro, LLCMBI2026-08-14
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