Arthrex®

Primary DI
00888867329126
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-8964-27
Catalog number
AR-8964-27
Device description
Straight Attachment Arm
Published
2019-11-15
Public version status
New
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
00888867329126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867329126008888673291268888673291260888867329126

GMDN Terms#

Term, Definition table
TermDefinition
General external orthopaedic fixation system implantation kit, reusableA collection of mostly instruments intended to be used to manipulate and prepare soft-tissue and bone for the adjustment or placement of the implantable components of an external orthopaedic fixation system in various skeletal areas (e.g., bones of limbs, spine, pelvis, craniomaxillofacial areas). It is a non-dedicated device that includes various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, cutters, screwdrivers, guides, tighteners) that are specific to the fixation system applied; the implant(s) is not included. 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
00888867007482Arthrex®AR-13100-05.0SAR-13100-05.0S2017-01-20
00888867007529Arthrex®AR-13100-09.0SAR-13100-09.0S2017-01-20
00888867007567Arthrex®AR-13100-11.0SAR-13100-11.0S2017-01-20
00888867007604Arthrex®AR-13100-15.0SAR-13100-15.0S2017-01-20
00888867007628Arthrex®AR-13100-17.5SAR-13100-17.5S2017-01-20
00888867008564Arthrex®AR-13200-03.0SAR-13200-03.0S2017-01-20
00888867204041Arthrex®AR-8952XLSAR-8952XLS2017-07-18
00888867210424Arthrex®AR-8933L-26SAR-8933L-26S2017-08-31
00888867210431Arthrex®AR-8933L-28SAR-8933L-28S2017-08-31
00888867210448Arthrex®AR-8933L-30SAR-8933L-30S2017-08-31
00888867210462Arthrex®AR-8933L-34SAR-8933L-34S2017-08-31
00888867210479Arthrex®AR-8933L-36SAR-8933L-36S2017-08-31
00888867210493Arthrex®AR-8933L-40SAR-8933L-40S2017-08-31
00888867251960Arthrex®AR-8958-01SAR-8958-01S2017-11-28
00888867266872Arthrex®AR-8952PPLAR-8952PPL2017-03-28
00888867266896Arthrex®AR-8952PSRAR-8952PSR2017-03-28
00888867266957Arthrex®AR-8952PPRAR-8952PPR2017-03-28
00888867371828Arthrex®AR-8924SAR-8924S2023-05-25
00888867251939Arthrex®AR-8958-02AR-8958-022017-02-15
00888867279285Arthrex®AR-7249-12-1AR-7249-12-12017-12-01

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
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