FDA.reportPublic FDA data

Fixation Button-Oblong

Primary DI
00850052601195
Brand
Fixation Button-Oblong
Company
DUNAMIS MEDICAL, LLC
Model
AB-6100
Catalog number
AB-6100
Device description
Fixation Button-Oblong
Published
2024-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTNWasher, Bolt Nut
MBIFastener, Fixation, Nondegradable, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTNWasher, Bolt NutOrthopedic2
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191319000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191319000Dunamis Fixation Button SystemDunamis, LLC2019-08-29MBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850052601195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850052601195008500526011958500526011950850052601195

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation suture buttonA small, implantable device designed to retain the loop of a ligature/suture to provide additional stability and accurate fixation during orthopaedic procedures, typically internal fixation of fractures with or without additional fixation devices (e.g., bone plates, screws). It can be of various shapes (e.g., H-shaped, round, oblong), made of non-bioabsorbable metallic materials [e.g., titanium (Ti)] and is typically implanted with dedicated implantation instruments; it may be supplied with associated sutures/ligatures.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-454-2186info@dunamismedical.com

Regulatory Flags#

DUNS number
079471560
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10854629006847Fastloop™ WhiteDFX24SLW2022-03-03
10854629006854Fastloop™ GreenDFX24SLG2022-03-03
00850052601317Olecranon Transporter™ Repair KitOL-2000OL-20002025-04-29
00850052601294Force DFX Suture Loop -Xtreme™DFX34XSLDFX0034S2025-04-10
40854629006916Orca™ Xtreme Knotless ButtonAB-6900AB-69002024-01-31
00854629006956Enofix ™ with Constrictor® Technology Syndesmotic Fixation Kit 3500-00-00013500-00-00012023-07-31
00850052601263Constrictor® Mini 2.0 Syndesmosis Repair Kit AB-3700AB-37002024-09-19
00850052601270Constrictor® 2.0 Syndesmosis Repair Kit AB-2700AB-27002024-09-19
00854629006789Constrictor® Mini Syndesmosis Repair Kit AB-3200AB-32002024-09-19
00850052601256Micro Constrictor ®X Repair KitAB-8700AB-87002024-09-19
00850052601249Orca™ Implantation Kit AB-6250AB-62502024-06-20
00850052601072Hallux GuideDU1000DU10002024-06-10
00850052601089CMC SpacerDNS000/DNS001DNS000/DNS0012024-06-10
00850052601096CMC GuideDU3000DU30002024-06-10
00850052601157Threaded Driver 100161010016102024-06-10
00850052601232Micro Constrictor® Implantation Kit AB-8250AB-69502024-06-10
00850052601225Orca Xtreme ™ Kit Knotless ButtonAB-6925AB-69252024-03-14
00850052601218Orca™ Xtreme Implantation Kit AB-6950AB-69502024-02-13
00854629006147PunchTac 3mm Anchor PEEKDFX0028ADFX0028A2017-04-11
00854629006161PunchTac 3.5mm Anchor PEEKDFX0029ADFX0029A2017-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024711280Jgrknt Reusable Fishmouth Perc GuideBiomet Orthopedics, LLCMBI2026-08-25
00889024712034Percutaneous Soft Anchor Short 1.4mm GuideBiomet Orthopedics, LLCMBI2026-08-25
00810198920178TeKBraceTheraMicro, LLCMBI2026-08-14
00811714036472ThunderboltRESPONSIVE ORTHOPEDICS LLCMBI2026-07-31
00811714036489ThunderboltRESPONSIVE ORTHOPEDICS LLCMBI2026-07-31
00810146164340RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164357RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164388RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164418RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164449RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164456RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164463RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164500RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164517RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164531RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164562RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164579RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164623RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164654RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164685RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164692RedifixTRAX SURGICAL INC.MBI2026-07-20
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