Arthrex®

Primary DI
00888867241237
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-8964R-450
Catalog number
AR-8964R-450
Device description
Carbon Rod, 450mm
Published
2017-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
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
00888867241237PrimaryGS10
M150AR8964R4500SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867241237008888672412378888672412370888867241237

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system, single-use, non-sterileAn assembly of non-sterile devices designed to stabilize fractured bones 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, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to 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
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
00888867514522Arthrex®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
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