FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867015272
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-1380C
Catalog number
AR-1380C
Device description
BIO-COMP INTERFSCRW W/DISP SHTH
Published
2017-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, fixation, bone
MAIFASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867015272PrimaryGS10
M150AR1380C1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867015272008888670152728888670152720888867015272

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, bioabsorbableA 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 is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). This device may be used in maxillofacial surgery. There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded. 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
00888867020498Arthrex®AR-1648AR-16482018-08-03
00888867319882Arthrex®AR-8980BCTAR-8980BCT2021-06-24
00888867501317Arthrex®AR-1588SBR-RTTAR-1588SBR-RTT2025-06-23
00888867328693Arthrex®AR-8933VCL-10SAR-8933VCL-10S2024-08-05
00888867328709Arthrex®AR-8933VCL-12SAR-8933VCL-12S2024-08-05
00888867328716Arthrex®AR-8933VCL-14SAR-8933VCL-14S2024-08-05
00888867328723Arthrex®AR-8933VCL-16SAR-8933VCL-16S2024-08-05
00888867328730Arthrex®AR-8933VCL-18SAR-8933VCL-18S2024-08-05
00888867328747Arthrex®AR-8933VCL-20SAR-8933VCL-20S2024-08-05
00888867328754Arthrex®AR-8933VCL-22SAR-8933VCL-22S2024-08-05
00888867328761Arthrex®AR-8933VCL-24SAR-8933VCL-24S2024-08-05
00888867328778Arthrex®AR-8933VCL-26SAR-8933VCL-26S2024-08-05
00888867328785Arthrex®AR-8933VCL-28SAR-8933VCL-28S2024-08-05
00888867328792Arthrex®AR-8933VCL-30SAR-8933VCL-30S2024-08-05
00888867328808Arthrex®AR-8933VCL-32SAR-8933VCL-32S2024-08-05
00888867328815Arthrex®AR-8933VCL-34SAR-8933VCL-34S2024-08-05
00888867328822Arthrex®AR-8933VCL-36SAR-8933VCL-36S2024-08-05
00888867328839Arthrex®AR-8933VCL-38SAR-8933VCL-38S2024-08-05
00888867328846Arthrex®AR-8933VCL-40SAR-8933VCL-40S2024-08-05
00888867328860Arthrex®AR-8933HVCL-12SAR-8933HVCL-12S2024-08-05

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Primary DI, Brand, Company table
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00196449002757LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
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