FDA.reportPublic FDA data

Arsenal Foot

Primary DI
00190446898818
Brand
Arsenal Foot
Company
Trilliant Surgical, LLC
Model
330-27-016
Device description
ARSENAL 2.7mm Drill Guide
Published
2025-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FZXGuide, surgical, instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190446898818PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446898818001904468988181904468988180190446898818

GMDN Terms#

Term, Definition table
TermDefinition
Osteotomy guide, reusableA surgical instrument intended to be attached to a bone (e.g., pelvis, femur, tibia, ulna) during an osteotomy procedure (including during joint arthroplasty) to outline/define the desired cut-line and mechanically support/guide the cutting device (e.g., oscillating cutting saw). This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
828829072
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
00190446898795Arsenal Foot330-00-0112025-07-01
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
00810028391956Arsenal Ankle307-27-0482022-05-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M739985202229Marking PinCAPTIVA SPINE, INC.FZX2026-10-28
M739985203229Marking PinCAPTIVA SPINE, INC.FZX2026-10-28
00889024702295OsseoFitZimmer, Inc.FZX2026-10-27
00889024702301OsseoFitZimmer, Inc.FZX2026-10-27
04250337119210Counter Pusher, greenJoimax GmbHFZX2026-10-27
04250337119227Counter Pusher, yellowJoimax GmbHFZX2026-10-27
04250337119234Counter Pusher, redJoimax GmbHFZX2026-10-27
M209232940Rose Proximal Cutting GuideBIOPRO, INC.FZX2026-10-27
M20923295Rose Distal Cutting GuideBIOPRO, INC.FZX2026-10-27
M739985202530Marking PinCAPTIVA SPINE, INC.FZX2026-10-23
M739985203530Marking PinCAPTIVA SPINE, INC.FZX2026-10-23
04250337117933Punching Adapter for Working TubeJoimax GmbHFZX2026-10-22
04250337119180Guiding Tube, eccentrically cannulated, redJoimax GmbHFZX2026-10-22
04250337119197Guiding Tube, eccentrically cannulated, purpleJoimax GmbHFZX2026-10-22
04250337119203Working Tube with Handle, oblique 45°Joimax GmbHFZX2026-10-22
04250337119562Guiding Tube, conicalJoimax GmbHFZX2026-10-22
04250337119579Guiding rod , conicalJoimax GmbHFZX2026-10-22
04250337119586Guiding rod , conicalJoimax GmbHFZX2026-10-22
04250337119593Working Tube with crown half teeth tipJoimax GmbHFZX2026-10-22
04250337119647Working Tube with handle, Standard lipJoimax GmbHFZX2026-10-22
04250337119678Guiding rod, conical, longitudinal slantedJoimax GmbHFZX2026-10-22
04250337119791Working Tube with long lipJoimax GmbHFZX2026-10-22
04250337120834Working tube, long lipJoimax GmbHFZX2026-10-22
04250337121862Working Tube with Handle, Standard LipJoimax GmbHFZX2026-10-22
04250337121909Working Tube with Handle, Standard LipJoimax GmbHFZX2026-10-22
04250337121916Working Tube with Handle, oblique 35°Joimax GmbHFZX2026-10-22
04250337121923Working Tube with Handle, oblique 35°Joimax GmbHFZX2026-10-22
04250337121930Working Tube with Handle, long lipJoimax GmbHFZX2026-10-22
04250337122029Guiding Rod, conicalJoimax GmbHFZX2026-10-22
04250337122036Guiding Rod, conical, greenJoimax GmbHFZX2026-10-22