FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867008380
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-13123-08
Catalog number
AR-13123-08
Device description
SCREW, CORTICAL, 2.3 MM X 8 MM, SS
Published
2017-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDRSTAPLE, FIXATION, BONE

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867008380PrimaryGS10
M150AR13123080SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867008380008888670083808888670083800888867008380

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)934-4404complaints@arthrex.com

Regulatory Flags#

DUNS number
131747628
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867543904Arthrex®AR-1101TH-13CT-SAR-1101TH-13CT-S2026-09-25
00888867543911Arthrex®AR-1101TH-8CT-SAR-1101TH-8CT-S2026-09-25
00888867543928Arthrex®AR-1101TH-13OT-SAR-1101TH-13OT-S2026-09-25
00888867543935Arthrex®AR-1101TH-8OT-SAR-1101TH-8OT-S2026-09-25
00888867460973Arthrex®AR-9001A-7140CSAR-9001A-7140CS2026-06-11
00888867291690Arthrex®AR-3350-4031AR-3350-40312018-12-13
00888867291751Arthrex®AR-3355-4031AR-3355-40312018-12-13
00888867161085Arthrex®AR-3350-4071AR-3350-40712018-12-13
00888867161207Arthrex®AR-3355-4071AR-3355-40712018-12-13
00888867504059Arthrex®AR-9650CAR-9650C2026-09-21
00888867504066Arthrex®AR-9650C-01AR-9650C-012026-09-21
00888867504073Arthrex®AR-9650C-02AR-9650C-022026-09-21
00888867570764Arthrex®AR-9650SFL-10256AR-9650SFL-102562026-09-21
00888867570771Arthrex®AR-9650SFL-11250AR-9650SFL-112502026-09-21
00888867550292Arthrex®AR-6533S-STAR-6533S-ST2026-09-18
00888867550308Arthrex®AR-6533S-XLAR-6533S-XL2026-09-18
00888867550315Arthrex®AR-6534S-STAR-6534S-ST2026-09-18
00888867550322Arthrex®AR-6534S-XLAR-6534S-XL2026-09-18
00888867550339Arthrex®AR-6533S-STSAR-6533S-STS2026-09-18
00888867550346Arthrex®AR-6533S-XLSAR-6533S-XLS2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867574342Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574359Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574366Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574373Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574380Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574397Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574403Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574410Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574427Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574434Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574441Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574458Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574465Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574595Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574601Arthrex®ARTHREX, INC.JDR2026-09-18
00811714036472ThunderboltRESPONSIVE ORTHOPEDICS LLCJDR2026-07-31
00811714036489ThunderboltRESPONSIVE ORTHOPEDICS LLCJDR2026-07-31
00810135964180VertexNVision Biomedical Technologies, Inc.JDR2025-12-17
00860005968824RELJA Innovations Nitinol Staple Kit 15mmx12mmRelja Innovations LLCJDR2025-09-19
00860005968831RELJA Innovations Nitinol Staple Kit 18x18Relja Innovations LLCJDR2025-09-19
10886705001033LUPINEDEPUY MITEK, LLCJDR2025-03-04
10886705001040LUPINEDEPUY MITEK, LLCJDR2025-03-04
07630037889397APTUSMedartis AGJDR2023-03-03
00810005661010VertexNVision Biomedical Technologies, Inc.JDR2020-12-28
00810005661027VertexNVision Biomedical Technologies, Inc.JDR2020-12-28
00810005661034VertexNVision Biomedical Technologies, Inc.JDR2020-12-28
00810005661041VertexNVision Biomedical Technologies, Inc.JDR2020-12-28
00810005661058VertexNVision Biomedical Technologies, Inc.JDR2020-12-28
00810005661065VertexNVision Biomedical Technologies, Inc.JDR2020-12-28
00810005661072VertexNVision Biomedical Technologies, Inc.JDR2020-12-28