FDA.reportPublic FDA data

Hallux Guide

Primary DI
00850052601072
Brand
Hallux Guide
Company
DUNAMIS MEDICAL, LLC
Model
DU1000
Catalog number
DU1000
Device description
Hallux Guide
Published
2024-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00850052601072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850052601072008500526010728500526010720850052601072

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
334-371-6280info@dunamismedical.com

Regulatory Flags#

DUNS number
079471560
Device count
1
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
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
00854629006178PunchTac 4.5mm AnchorDFX0030ADFX0030A2017-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00850080543009PC Fix Locking Post TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543016PC Fix Locking Cap TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543023PC Fix Washer TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543030PC Fix Extrathoracic Plate 70mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543047PC Fix Extrathoracic Plate 95mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543054PC Fix Intrathoracic Plate 70mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543061PC Fix Intrathoracic Plate 95mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543078PC Fix Thoracic Plate 70mm PEEKChest Wall Innovations, Inc.HTN2026-06-01
00850080543085PC Fix Thoracic Plate 95mm PEEKChest Wall Innovations, Inc.HTN2026-06-01
00850080543092PC Fix 3.2mm Drill Brad Point QCChest Wall Innovations, Inc.HTN2026-06-01
00850080543108PC Fix Graphic CaseChest Wall Innovations, Inc.HTN2026-06-01
00850080543115PC Fix Clamp/Drill Guide TopChest Wall Innovations, Inc.HTN2026-06-01
00850080543122PC Fix Clamp/Drill Guide BottomChest Wall Innovations, Inc.HTN2026-06-01
00850080543139PC Fix Compression ClampChest Wall Innovations, Inc.HTN2026-06-01
00850080543146PC Fix 3.2mm Drill Dental LatchChest Wall Innovations, Inc.HTN2026-06-01
00850080543184PC Fix Implant CaddyChest Wall Innovations, Inc.HTN2026-06-01
07901125602533Expert KnotlessGM DOS REIS INDUSTRIA E COMERCIO LTDAHTN2026-05-28
09353903030003Griplasty SystemFIELD ORTHOPAEDICS PTY LTDMBI2024-09-19
00888867251960Arthrex®ARTHREX, INC.HTN2017-11-28
00888867251939Arthrex®ARTHREX, INC.HTN2017-02-15
00888867026483Arthrex®ARTHREX, INC.MBI2017-02-15
07613327075830ASNISStryker GmbHHTN2015-11-11
07613327076189ASNISStryker GmbHHTN2015-11-11
07613327076301ASNISStryker GmbHHTN2015-11-11
07613327076554ASNISStryker GmbHHTN2015-11-11
07613327076721ASNISStryker GmbHHTN2015-11-11