Arthrex®

Primary DI
00888867514522
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-8964-28
Catalog number
AR-8964-28
Device description
Coupler Wrench
Published
2025-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDKSYSTEM, EXTERNAL FIXATOR (WITH METALLIC INVASIVE COMPONENTS)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDKSystem, External Fixator (With Metallic Invasive Components)Orthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122208000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122208000EXTERNAL FIXATOR SYSTEMChristopher D. Endara2012-12-20NDK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867514522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867514522008888675145228888675145220888867514522

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system, reusableAn assembly of devices designed to stabilize fractured bones, other than those in the vertebral column, to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, cams, bushings, collars, bolts and nuts; it may also include some instrumentation (e.g., screw drivers, wrenches, drills). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the wrist, elbow, knee, hip and ankle, joint fusions, and limb lengthening. This is a reusable device.

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
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867050037Arthrex®AR-8933L-14SAR-8933L-14S2017-08-31
00888867050051Arthrex®AR-8933L-16SAR-8933L-16S2017-08-31
00888867050075Arthrex®AR-8933L-18SAR-8933L-18S2017-08-31
00888867051324Arthrex®AR-8940-16SAR-8940-16S2017-03-03
00888867051348Arthrex®AR-8940-18SAR-8940-18S2017-03-03
00888867051386Arthrex®AR-8940-22SAR-8940-22S2017-03-03
00888867051447Arthrex®AR-8940-28SAR-8940-28S2017-03-03
00888867051485Arthrex®AR-8940-32SAR-8940-32S2017-03-03
00888867051560Arthrex®AR-8940-40SAR-8940-40S2017-03-03
00888867051584Arthrex®AR-8940-42SAR-8940-42S2017-03-03
00888867053304Arthrex®AR-8945-22FTSAR-8945-22FTS2017-08-31
00888867053496Arthrex®AR-8945-30PTSAR-8945-30PTS2017-08-31
00888867053533Arthrex®AR-8945-32PTSAR-8945-32PTS2017-08-31
00888867053649Arthrex®AR-8945-36PTSAR-8945-36PTS2017-08-31
00888867053687Arthrex®AR-8945-38PTSAR-8945-38PTS2017-08-31
00888867053724Arthrex®AR-8945-40PTSAR-8945-40PTS2017-08-31
00888867053755Arthrex®AR-8945-45FTSAR-8945-45FTS2017-08-31
00888867053816Arthrex®AR-8945-50PTSAR-8945-50PTS2017-08-31
00888867053854Arthrex®AR-8945-55PTSAR-8945-55PTS2017-08-31
00888867053892Arthrex®AR-8945-60PTSAR-8945-60PTS2017-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867514508Arthrex®ARTHREX, INC.NDK2025-03-26
00888867514515Arthrex®ARTHREX, INC.NDK2025-03-26
10888867241401Arthrex®ARTHREX, INC.NDK2021-12-03
00888867329126Arthrex®ARTHREX, INC.NDK2019-11-15
00888867241039Arthrex®ARTHREX, INC.NDK2017-02-15
00888867241121Arthrex®ARTHREX, INC.NDK2017-02-15
00888867241169Arthrex®ARTHREX, INC.NDK2017-02-15
00888867241176Arthrex®ARTHREX, INC.NDK2017-02-15
00888867241183Arthrex®ARTHREX, INC.NDK2017-02-15
00888867241190Arthrex®ARTHREX, INC.NDK2017-02-15
00888867241206Arthrex®ARTHREX, INC.NDK2017-02-15
00888867241213Arthrex®ARTHREX, INC.NDK2017-02-15
00888867241220Arthrex®ARTHREX, INC.NDK2017-02-15
00888867241237Arthrex®ARTHREX, INC.NDK2017-02-15
00888867241244Arthrex®ARTHREX, INC.NDK2017-02-15
00888867241046Arthrex®ARTHREX, INC.NDK2017-02-15
00888867241251Arthrex®ARTHREX, INC.NDK2017-02-15
00888867241107Arthrex®ARTHREX, INC.NDK2017-02-15
00888867241114Arthrex®ARTHREX, INC.NDK2017-02-15
00888867241138Arthrex®ARTHREX, INC.NDK2017-02-15
00888867241145Arthrex®ARTHREX, INC.NDK2017-02-15
00888867241152Arthrex®ARTHREX, INC.NDK2017-02-15
00888867241268Arthrex®ARTHREX, INC.NDK2017-02-15
00888867241275Arthrex®ARTHREX, INC.NDK2017-02-15
00888867241909Arthrex®ARTHREX, INC.NDK2017-02-15