FDA.reportPublic FDA data

FlexBand Plus

Primary DI
00850003396088
Brand
FlexBand Plus
Company
Artelon
Model
41052
Catalog number
41052
Published
2019-12-27
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

Product Codes#

Code, Name table
CodeName
FTLMesh, Surgical, Polymeric
MBIFastener, Fixation, Nondegradable, Soft Tissue
QWJMesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTLMesh, Surgical, PolymericGeneral, Plastic Surgery2
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2
QWJMesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of LigamentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192112000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192112000FlexBand PlusInternational Life Sciences2019-09-27FTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850003396088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850003396088008500033960888500033960880850003396088

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, bioabsorbable, monofilamentA single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester (e.g., polydioxanone, poliglecaprone, polycaprolactone, polyglyconate, polyhydroxybutyrate) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis; it may include an attached disposable needle. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device intended to be used in a sterile condition.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length15Centimeter
Length16Centimeter
Width0.3Centimeter

Sterilization Methods#

Method table
Method
Ethylene Oxide;Radiation Sterilization

Regulatory Flags#

DUNS number
066284070
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850003396217FLEXBAND FIX51013510132023-05-24
00850003396248FlexBandTW012TW0122024-04-11
00850003396323FlexBandTW030TW0302024-04-11
00850003396187FlexBand Plus41068410682023-05-24
00850003396286FlexBand71004710042023-05-24
00850003396163FlexBand71016710162021-02-25
00850003396170FlexBand51004510042021-02-25
00868047000304FlexPatch31048310482019-12-23
00868047000311FlexPatch31050310502019-12-23
00868047000328FlexPatch31049310492019-12-23
00868047000335FlexBand31051310512019-12-23
00868047000342FlexBand31052310522019-12-23
00868047000359FlexBand31053310532019-12-23
00868047000366FlexBand31054310542019-12-23
00868047000373FlexBand31055310552019-12-23
00868047000380FlexBand31056310562019-12-23
00868047000397FlexBand31058310582019-12-23
00850003396033FlexBand Plus41057410572019-12-27
00850003396040FlexBand Plus41056410562019-12-27
00850003396057FlexBand Plus41055410552019-12-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860016070004ICONN Revolution 6.5MM Knotless Suture AnchorICONN ORTHOPEDICS LLCMBI2026-07-16
10810128462867VersiTILT 2.4 x 8.5mm Implant SystemT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462874VersiTILT 2.4 x 8.5mm Button and InserterT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462881VersiTILT Drill Pin, 3.1mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462898VersiTILT Button, 2.4x8.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462904VersiTILT 2.4x12mm Implant System, LongT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462911VersiTILT 2.4x12mm Button and Inserter, LongT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462928VersiTILT Button, 2.4x12mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462935VersiTILT 3.1x10.9mm Implant System, XLT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462942VersiTILT 3.1x10.9mm Button and Inserter, XLT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462959VersiTILT Drill Pin, 3.6mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462966VersiTILT Button, 3.1x10.9mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
00810155331412Tigon MedicalTigon Medical LLCMBI2026-07-09
05060267134561FORCECORD ImplantXIROS LTDFTL2026-07-06
00850029805106Tigon MedicalTigon Medical LLCMBI2026-06-26
07901125601130GMReis Suture AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDAMBI2026-06-25
09353903030201Griplasty SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-06-24
00860013918606ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
00860013918613ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
00860013918620ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
00860013918637ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
08720629959573SINEFIXBaat Medical Products B.V.MBI2026-04-01
08721515510151SINEFIXBaat Medical Products B.V.MBI2026-04-01
08101755018820HerculesIn2Bones USA, LLCMBI2026-03-30
08437019739744QuadLock™ Fixation System 9mmABANZA TECNOMED SL.MBI2026-01-14
08437019739751QuadLock™ Fixation System 10mmABANZA TECNOMED SL.MBI2026-01-14
08437019739768QuadLock™ Fixation System 11mmABANZA TECNOMED SL.MBI2026-01-14
00888867465220Arthrex®ARTHREX, INC.MBI2025-06-23
00888867465237Arthrex®ARTHREX, INC.MBI2025-06-23
00888867465244Arthrex®ARTHREX, INC.MBI2025-06-23