FDA.reportPublic FDA data

Enofix ™ with Constrictor® Technology Syndesmotic Fixation Kit

Primary DI
00854629006956
Brand
Enofix ™ with Constrictor® Technology Syndesmotic Fixation Kit
Company
DUNAMIS MEDICAL, LLC
Model
3500-00-0001
Catalog number
3500-00-0001
Device description
Enofix ™ with Constrictor® Technology Syndesmotic Fixation Kit
Published
2023-07-31
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

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTNWasher, Bolt NutOrthopedic2
HTWBit, DrillOrthopedic1
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854629006956PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854629006956008546290069568546290069560854629006956

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
Kit
true
Lot or batch
true
Expiration date on label
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
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
00854629006178PunchTac 4.5mm AnchorDFX0030ADFX0030A2017-04-11

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00860013918620ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
00860013918637ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
04052536176700neon3Ulrich GmbH & Co. KGHTW2026-06-08
04052536176717neon3Ulrich GmbH & Co. KGHTW2026-06-08
00196449017355A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
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