Arsenal Foot

Primary DI
00810028390331
Brand
Arsenal Foot
Company
Trilliant Surgical, LLC
Model
307-22-014
Device description
2.2mm x 14mm Arsenal Screw
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
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, 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
00810028390331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810028390331008100283903318100283903310810028390331

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
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

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