FDA.reportPublic FDA data

Arsenal Ankle

Primary DI
00810028391727
Brand
Arsenal Ankle
Company
Trilliant Surgical, LLC
Model
340-60-005
Device description
.062in x 3in Olive Wire, Arsenal Ankle
Published
2022-05-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

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
00810028391727PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810028391727008100283917278100283917270810028391727

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10888857613812K2M General InstrumentsVB Spine LLCLXH2026-06-12
10888857613805Xia® 3VB Spine LLCLXH2026-06-11
10888857596900OZARK Cervical Plate SystemVB Spine LLCLXH2026-05-01
10888857596917OZARK Cervical Plate SystemVB Spine LLCLXH2026-05-01
10888857596924OZARK Cervical Plate SystemVB Spine LLCLXH2026-05-01
10888857596931OZARK Cervical Plate SystemVB Spine LLCLXH2026-05-01
10888857596948OZARK Cervical Plate SystemVB Spine LLCLXH2026-05-01
07640176970740Resection CheckerNaviswiss AGLXH2025-08-12
07640176970108Set of NAVItags (sterile, single-use)Naviswiss AGLXH2024-05-16
07640176970115Tag adapter PNaviswiss AGLXH2024-05-16
07640176970122Tag adapter M (magnetic)Naviswiss AGLXH2024-05-16
07640176970153Hex screwdriver SW3.5mm (AO coupling)Naviswiss AGLXH2024-05-16
07640176970177Tag adapter FNaviswiss AGLXH2024-05-16
07640176970191Pelvic caliperNaviswiss AGLXH2024-05-16
07640176970214Speed pin (3.0 x 80 mm, wear part)Naviswiss AGLXH2024-05-16
07640176970221Speed pin adapterNaviswiss AGLXH2024-05-16
07640176970238Cortical bone screwNaviswiss AGLXH2024-05-16
07640176970252Calibration barNaviswiss AGLXH2024-05-16
07640176970320Tag adapter M (quick-lock)Naviswiss AGLXH2024-05-16
07640176970337PointerNaviswiss AGLXH2024-05-16
07640176970375Hex screwdriver SW3.5mm spherical headNaviswiss AGLXH2024-05-16
07640176970467Cortical bone screw (self drilling, 3.5 x 23 mm, wear part)Naviswiss AGLXH2024-05-16
07640176970481Single-pin tag mount (self-drilling, wear part)Naviswiss AGLXH2024-05-16
07640176970498Single-pin tag mount AO adapterNaviswiss AGLXH2024-05-16
07640176970511Speed pin (3.0 x 110 mm, wear part)Naviswiss AGLXH2024-05-16
07640176970542Acetabular Adapter PNaviswiss AGLXH2024-05-16
07640176970610Single-pin tag mount short (self drilling, wear part)Naviswiss AGLXH2024-05-16