FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867328839
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-8933VCL-38S
Catalog number
AR-8933VCL-38S
Device description
VAL KreuLock Screw, Ti, 3.0x38, Strl
Published
2024-08-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, fixation, bone

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867328839PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867328839008888673288398888673288390888867328839

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

Contacts#

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

Regulatory Flags#

DUNS number
131747628
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00888867328846Arthrex®AR-8933VCL-40SAR-8933VCL-40S2024-08-05
00888867328860Arthrex®AR-8933HVCL-12SAR-8933HVCL-12S2024-08-05
00888867328877Arthrex®AR-8933HVCL-14SAR-8933HVCL-14S2024-08-05

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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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00196449002771LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002788LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
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00196449002801LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08