FDA.reportPublic FDA data

Arsenal Foot

Primary DI
00810028390010
Brand
Arsenal Foot
Company
Trilliant Surgical, LLC
Model
300-81-002
Device description
Arsenal Mini Condylar Plate, Long
Published
2019-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191009000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191009000Arsenal Plating SystemTrilliant Surgical2019-08-12HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810028390010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810028390010008100283900108100283900100810028390010

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbable, non-sterileA non-sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion). This device is 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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00190446932406Arsenal Foot330-22-0132026-06-25
00190446934196Arsenal Foot330-00-0242026-06-25
00190446934202Arsenal Foot330-00-0232026-06-25
00190446934417Arsenal Foot330-01-3062026-06-25
00190446934424Arsenal Foot330-01-3102026-06-25
00190446934431Arsenal Foot330-01-3092026-06-25
00190446934448Arsenal Foot330-01-2182026-06-25
00190446934455Arsenal Foot330-01-2172026-06-25
00190446944331Arsenal Foot300-85-0152026-06-25
00190446944348Arsenal Foot300-85-0162026-06-25
00190446948216Arsenal Foot330-22-0032026-06-25
00190446948377Arsenal Foot330-84-0012026-06-25
00190446948438Arsenal Foot330-84-0022026-06-25
00190446948483Arsenal Foot330-84-0072026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630894822858APTUSMedartis AGHRS2026-07-16
07630894822865APTUSMedartis AGHRS2026-07-16
07630894822872APTUSMedartis AGHRS2026-07-16
07630894822889APTUSMedartis AGHRS2026-07-16
07630894822896APTUSMedartis AGHRS2026-07-16
07630894822902APTUSMedartis AGHRS2026-07-16
07630894822919APTUSMedartis AGHRS2026-07-16
07630894822926APTUSMedartis AGHRS2026-07-16
07630894822933APTUSMedartis AGHRS2026-07-16
07630894822940APTUSMedartis AGHRS2026-07-16
07630894822957APTUSMedartis AGHRS2026-07-16
07630894822964APTUSMedartis AGHRS2026-07-16
07630894822971APTUSMedartis AGHRS2026-07-16
07630894822988APTUSMedartis AGHRS2026-07-16
07630894822995APTUSMedartis AGHRS2026-07-16
07630894823008APTUSMedartis AGHRS2026-07-16
07630894823015APTUSMedartis AGHRS2026-07-16
07630894823022APTUSMedartis AGHRS2026-07-16
07630894823039APTUSMedartis AGHRS2026-07-16
07630894823053APTUSMedartis AGHRS2026-07-16
07630894823060APTUSMedartis AGHRS2026-07-16
07630894823084APTUSMedartis AGHRS2026-07-16
07630894823091APTUSMedartis AGHRS2026-07-16
07630894823114APTUSMedartis AGHRS2026-07-16
07630894823121APTUSMedartis AGHRS2026-07-16
07630894823145APTUSMedartis AGHRS2026-07-16
07630894823152APTUSMedartis AGHRS2026-07-16
07630894823176APTUSMedartis AGHRS2026-07-16
07630894823183APTUSMedartis AGHRS2026-07-16
07630894823206APTUSMedartis AGHRS2026-07-16