FDA.reportPublic FDA data

Arsenal Foot

Primary DI
00810028392106
Brand
Arsenal Foot
Company
Trilliant Surgical, LLC
Model
303-90-001
Device description
Arsenal 2.7/3.5mm/4.0mm Screw Washer, Smooth
Published
2022-05-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NDGWasher, Bolt, Nut, Non-Spinal, Metallic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDGWasher, Bolt, Nut, Non-Spinal, MetallicOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212378000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212378000Arsenal Ankle Plating SystemTrilliant Surgical2022-02-23HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810028392106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810028392106008100283921068100283921060810028392106

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone washer, non-sterileA non-sterile flat thin ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810028393431STAR PSI Tibia Cut Guide601-01-0002022-11-30
00810028393448STAR PSI Tibia Anatomical Model601-01-0012022-11-30
00810028393455STAR PSI Talus Cut Guide601-02-0002022-11-30
00810028393462STAR PSI Talus Anatomical Model601-02-0012022-11-30
00810028394971STAR PSI Standard Bundle with Anatomical Models601-00-0012022-11-30
0081292602720310mm Evans Plate300-54-2102017-03-15
0081292602721012mm Evans Plate300-54-2122017-03-15
00812926027791Tissue Retractor317-00-0072018-09-23
00812926027869Subtalar Implant System Sterilization Tray Lid112-99-0112018-09-23
0081292602851410 Hole Gridlock Helical Plate, Right300-65-0042018-10-15
00812926027036Tiger210-00-1022018-09-23
00812926027890Tiger210-99-1122018-09-23
00812926028002Gridlock320-99-1132018-09-23
00812926028026Gridlock310-00-0212018-09-23
00190446972020Generic Instrument215-00-0072026-07-16
00190446972037Generic Instrument215-00-0082026-07-16
00190446900498Arsenal Foot330-60-0072026-06-25
00190446900504Arsenal Foot330-60-0082026-06-25
00190446917861Arsenal Foot330-01-2152026-06-25
00190446917878Arsenal Foot330-01-2162026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998470431Solventum™ Bair Hugger™Solventum US LLCNDG2026-04-29
00197998470455Solventum™ Bair Hugger™Solventum US LLCNDG2026-04-29
08800089451005Summa Orthopaedics System Bone ScrewJeil Medical CorporationNDG2024-09-25
08800089446643ARIX System Bone ScrewJeil Medical CorporationNDG2024-03-19
00842188125362WashersTrimed, INC.NDG2023-01-05
05055662967555Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDNDG2022-05-25
00810028392113Arsenal FootTrilliant Surgical, LLCNDG2022-05-02
00810028392120TigerTrilliant Surgical, LLCNDG2022-05-02
08800089420391INLET System Bone ScrewJeil Medical CorporationNDG2021-11-19
08800089420407INLET System Bone ScrewJeil Medical CorporationNDG2021-11-19
05055662964844Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDNDG2021-06-25
00885556784006EVOSSmith & Nephew, Inc.NDG2021-05-11
00885556784013EVOSSmith & Nephew, Inc.NDG2021-05-11
00885556784020EVOSSmith & Nephew, Inc.NDG2021-05-11
00885556784037EVOSSmith & Nephew, Inc.NDG2021-05-11
20885556746022SMART TSFSmith & Nephew, Inc.NDG2020-11-03
00885556746028SMART TSFSmith & Nephew, Inc.NDG2020-11-03
00885556746035SMART TSFSmith & Nephew, Inc.NDG2020-11-03
08806390891912Prometheus System Bone ScrewJeil Medical CorporationNDG2020-09-01
08806390891929Prometheus System Bone ScrewJeil Medical CorporationNDG2020-09-01
08806390891936Prometheus System Bone ScrewJeil Medical CorporationNDG2020-09-01
08806390858014VERUM System Bone ScrewJeil Medical CorporationNDG2020-03-20
08806390858021VERUM System Bone ScrewJeil Medical CorporationNDG2020-03-20
08806390865821Summa Orthopaedics System Bone ScrewJeil Medical CorporationNDG2020-03-20
08806390865838Summa Orthopaedics System Bone ScrewJeil Medical CorporationNDG2020-03-20
08806390883641Summa Orthopaedics System Bone ScrewJeil Medical CorporationNDG2020-02-18
08806390850742ARIX System Bone ScrewJeil Medical CorporationNDG2019-12-12
08806390862288ARIX System Bone ScrewJeil Medical CorporationNDG2019-12-12
08809282815508ARIX System Bone ScrewJeil Medical CorporationNDG2019-12-12
08809282815515ARIX System Bone ScrewJeil Medical CorporationNDG2019-12-12