FDA.reportPublic FDA data

Arsenal Foot

Primary DI
00190446898801
Brand
Arsenal Foot
Company
Trilliant Surgical, LLC
Model
330-60-006
Device description
0.062 Smooth Olive Wire
Published
2026-03-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190446898801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446898801001904468988011904468988010190446898801

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone-fragment manipulator, single-useA hand-held manual surgical instrument designed to help position a fractured fragment of bone to achieve proper alignment (reduction). It is typically a long, thin, rigid rod made of high-grade stainless steel with a self-drilling/self-tapping screw thread at the distal end and a connector at the proximal end to attach an appropriate handle. The device is usually inserted transcutaneously to the fractured section of bone (e.g., through the skin and into a craniofacial fracture) and removed after positioning and fixation of the fracture. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
828829072
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810028397385Tiger201-30-0422024-06-04
00810028399099Tiger201-40-2102024-06-04
00810028399464Tiger203-20-0162024-06-04
00850062461949Tibial Impactor Tips 920-0061-042024-08-09
00810028391840Arsenal Ankle340-00-0032022-05-02
00812926028804Hook Tamp320-00-0202019-03-11
008129260201293S Hemi111-00-0022018-09-23
008129260202283S Hemi111-00-0122018-09-23
00812926027043Two-Step Hammertoe214-00-0142018-09-23
008129260280333S Hemi111-00-0132018-09-23
00812926028187Staple Tamp510-00-0052018-09-23
00810028398344Tiger201-20-0082024-05-31
00810028395343Arsenal Foot300-82-0252024-03-27
00810028395206Arsenal Foot300-82-0112024-03-21
00810028395213Arsenal Foot300-82-0122024-03-21
00810028395220Arsenal Foot300-82-0132024-03-21
00810028395237Arsenal Foot300-82-0142024-03-21
00810028395244Arsenal Foot300-82-0152024-03-21
00810028395251Arsenal Foot300-82-0162024-03-21
00810028395268Arsenal Foot300-82-0172024-03-21

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