FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867013940
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-1358
Catalog number
AR-1358
Device description
SCREW, CANCELLOUS, LOW PROFILE
Published
2017-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, fixation, bone
MAIFASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
MBIFastener, fixation, nondegradable, soft tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2
MAIFastener, Fixation, Biodegradable, Soft TissueOrthopedic2
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867013940PrimaryGS10
M150AR13582SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867013940008888670139408888670139400888867013940

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, 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). There are a number of kinds available: 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 across bone fragments.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
131747628
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867620964Arthrex®AR-3210-0067AR-3210-00672026-10-12
00888867620971Arthrex®AR-3210-0067-PKAR-3210-0067-PK2026-10-12
00888867620988Arthrex®AR-3210-0068AR-3210-00682026-10-12
00888867620995Arthrex®AR-3210-0068-PKAR-3210-0068-PK2026-10-12
00888867520745Arthrex®AR-1360FT-KFTAR-1360FT-KFT2026-01-21
00888867429857Arthrex®AR-2600FSB-1AR-2600FSB-12023-05-24
00888867429864Arthrex®AR-2600FSB-2AR-2600FSB-22023-05-24
00888867429871Arthrex®AR-2600FSB-3AR-2600FSB-32023-05-24
00888867429888Arthrex®AR-2600FSB-4AR-2600FSB-42023-05-24
00888867354067Arthrex®AR-1360FT-BCAR-1360FT-BC2020-12-15
00888867101951Arthrex®AR-3600DCAR-3600DC2018-12-21
00888867096066Arthrex®AR-1677BC-CPAR-1677BC-CP2017-02-15
00888867084384Arthrex®ABS-3005ABS-30052017-02-15
00888867084407Arthrex®ABS-3008ABS-30082017-02-15
00888867084421Arthrex®ABS-3016ABS-30162017-02-15
00888867084148Arthrex®ABS-2001-01ABS-2001-012017-02-15
00888867084155Arthrex®ABS-2001-02ABS-2001-022017-02-15
00888867084162Arthrex®ABS-2001-05ABS-2001-052017-02-15
00888867084179Arthrex®ABS-2001-10ABS-2001-102017-02-15
00888867084186Arthrex®ABS-2002-01ABS-2002-012017-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14053613298657KOMET GUIDE PIN/SCREWGebr. Brasseler GmbH & Co. KGHWC2026-10-14
00860013918606ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
00888867520745Arthrex®ARTHREX, INC.MBI2026-01-21
00840277407962JuggerKnotless® Soft AnchorRIVERPOINT MEDICAL, LLCMBI2025-10-13
00840277407979JuggerKnotless® Soft AnchorRIVERPOINT MEDICAL, LLCMBI2025-10-13
00840277407986JuggerKnotless® Soft AnchorRIVERPOINT MEDICAL, LLCMBI2025-10-13
00840277407993JuggerLoop™ Soft AnchorRIVERPOINT MEDICAL, LLCMBI2025-10-13
00840277408006JuggerLoop™ Soft AnchorRIVERPOINT MEDICAL, LLCMBI2025-10-13
00840277408013JuggerLoop™ Soft AnchorRIVERPOINT MEDICAL, LLCMBI2025-10-13
00840277408020JuggerLoop™ Soft AnchorRIVERPOINT MEDICAL, LLCMBI2025-10-13
00840277407955JuggerKnotless Soft AnchorRIVERPOINT MEDICAL, LLCMBI2025-07-29
07613327662030ALPHAVENTSTRYKER CORPORATIONMBI2025-06-16
07613327662030ALPHAVENTSTRYKER CORPORATIONMAI2025-06-16
07613327662047ALPHAVENTSTRYKER CORPORATIONMAI2025-06-16
07613327662047ALPHAVENTSTRYKER CORPORATIONMBI2025-06-16
00840277405012OC JuggerKnotless® Soft AnchorRIVERPOINT MEDICAL, LLCMAI2024-12-19
00840277405012OC JuggerKnotless® Soft AnchorRIVERPOINT MEDICAL, LLCMBI2024-12-19
00840277405029OC JuggerKnotless® Soft AnchorRIVERPOINT MEDICAL, LLCMAI2024-12-19
00840277405029OC JuggerKnotless® Soft AnchorRIVERPOINT MEDICAL, LLCMBI2024-12-19
00840277405036OC JuggerKnotless® Soft AnchorRIVERPOINT MEDICAL, LLCMAI2024-12-19
00840277405036OC JuggerKnotless® Soft AnchorRIVERPOINT MEDICAL, LLCMBI2024-12-19
00840277405043OC JuggerKnotless® Soft AnchorRIVERPOINT MEDICAL, LLCMBI2024-12-19
00840277405043OC JuggerKnotless® Soft AnchorRIVERPOINT MEDICAL, LLCMAI2024-12-19
00840277405050OC JuggerLoop™ Soft AnchorRIVERPOINT MEDICAL, LLCMBI2024-12-19
00840277405050OC JuggerLoop™ Soft AnchorRIVERPOINT MEDICAL, LLCMAI2024-12-19
00840277405067OC JuggerLoop™ Soft AnchorRIVERPOINT MEDICAL, LLCMBI2024-12-19
00840277405067OC JuggerLoop™ Soft AnchorRIVERPOINT MEDICAL, LLCMAI2024-12-19
00840277405074OC JuggerLoop™ Soft AnchorRIVERPOINT MEDICAL, LLCMBI2024-12-19
00840277405074OC JuggerLoop™ Soft AnchorRIVERPOINT MEDICAL, LLCMAI2024-12-19
00840277405081OC JuggerLoop™ Soft Anchor SPRIVERPOINT MEDICAL, LLCMBI2024-12-19