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
00190446898795Arsenal Foot330-00-0112025-07-01
00190446898818Arsenal Foot330-27-0162025-07-01
00190446898825Arsenal Foot330-35-0162025-07-01
00190446898832Arsenal Foot330-00-0172025-07-01
00190446910091Arsenal Foot330-01-3012025-07-01
00190446910459Arsenal Foot330-01-3022025-07-01
00190446910466Arsenal Foot330-01-3032025-07-01
00190446910473Arsenal Foot330-01-3042025-07-01
00190446910480Arsenal Foot330-01-3052025-07-01
00190446910497Arsenal Foot330-01-3072025-07-01
00190446910503Arsenal Foot330-01-3082025-07-01
00810028395152Arsenal Ankle211-00-0082024-03-21
00810028391666Arsenal Ankle340-15-0032022-05-02
00810028391697Arsenal Ankle340-15-0072022-05-02
00810028391703Arsenal Ankle211-40-0012022-05-02
00810028391710Arsenal Ankle211-40-0022022-05-02
00810028391758Arsenal Ankle211-40-0042022-05-02
00810028391925Arsenal Ankle307-27-0422022-05-02
00810028391932Arsenal Ankle307-27-0442022-05-02
00810028391949Arsenal Ankle307-27-0462022-05-02

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