FDA.reportPublic FDA data

Ext. MUA Screw

Primary DI
00810157314987
Brand
Ext. MUA Screw
Company
Paragon Implant Mfg., LLC
Model
TXMA-61R
Catalog number
TXMA-61R
Device description
TriActive Ext. MUA, RP 1mmL, M1.4
Published
2026-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NJAAccessory, System, External Fixator, Containing Antimicrobial Agent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJAAccessory, System, External Fixator, Containing Antimicrobial AgentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K261392000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K261392000TriActive Dental Implant SystemParagon Implant Mfg., LLC2026-09-17DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810157314987PrimaryGS10
00810157315281Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810157314987008101573149878101573149870810157314987
00810157315281008101573152818101573152810810157315281

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis/implant abutment screwA device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Outer Diameter0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-855-649-4365info@paragon-implant.com

Regulatory Flags#

DUNS number
118698566
Device count
2
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810157315724Friction-Fit Removal ToolFFRT1.6FFRT1.62026-09-22
00810157315731Friction-Fit Removal ToolFFRT2.0FFRT2.02026-09-22
00810157313867TriActive ImplantTA3208TA32082026-09-21
00810157314048TriActive ImplantTA3210TA32102026-09-21
00810157314161TriActive ImplantTA3211TA32112026-09-21
00810157314208TriActive ImplantTA3213TA32132026-09-21
00810157314536TriActive ImplantTA3215TA32152026-09-21
00810157314543TriActive ImplantTA3707TA37072026-09-21
00810157314550TriActive ImplantTA3708TA37082026-09-21
00810157314567TriActive ImplantTA3710TA37102026-09-21
00810157314574TriActive ImplantTA3711TA37112026-09-21
00810157314581TriActive ImplantTA3713TA37132026-09-21
00810157314598TriActive ImplantTA3715TA37152026-09-21
00810157314604TriActive ImplantTA4307TA43072026-09-21
00810157314611TriActive ImplantTA4308TA43082026-09-21
00810157314628TriActive ImplantTA4310TA43102026-09-21
00810157314635TriActive ImplantTA4311TA43112026-09-21
00810157314642TriActive ImplantTA4313TA43132026-09-21
00810157314659TriActive ImplantTA43152026-09-21
00810157314666TriActive ImplantTA5007TA50072026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840124514133TopLockFUSION ORTHOPEDICS, LLCNJA2025-09-25
00840124514140TopLockFUSION ORTHOPEDICS, LLCNJA2025-09-25
00840124521551FuzeFix Max FTFUSION ORTHOPEDICS, LLCNJA2025-09-17
00840124521568FuzeFix Max FTFUSION ORTHOPEDICS, LLCNJA2025-09-17
00840124521575FuzeFix Max FTFUSION ORTHOPEDICS, LLCNJA2025-09-17
00840124521582FuzeFix Max FTFUSION ORTHOPEDICS, LLCNJA2025-09-17
00840124521636FuzeFix Max FTFUSION ORTHOPEDICS, LLCNJA2025-09-17
00840124521643FuzeFix Max FTFUSION ORTHOPEDICS, LLCNJA2025-09-17
00840124518919FuzeFix LargeFUSION ORTHOPEDICS, LLCNJA2025-05-14
00840124518926FuzeFix LargeFUSION ORTHOPEDICS, LLCNJA2025-05-14
00840124518933FuzeFix LargeFUSION ORTHOPEDICS, LLCNJA2025-05-14
00840124519152IntraLockFUSION ORTHOPEDICS, LLCNJA2025-05-14
00840124519176IntraLockFUSION ORTHOPEDICS, LLCNJA2025-05-14
00840124518896FuzeFix LargeFUSION ORTHOPEDICS, LLCNJA2025-05-13
00840124518902FuzeFix LargeFUSION ORTHOPEDICS, LLCNJA2025-05-13
00840124507623PolyLock SmallBoneFUSION ORTHOPEDICS, LLCNJA2023-06-12