FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867340176
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-2658BLO
Catalog number
AR-2658BLO
Device description
KL AC TIGHTROPE OPEN REPAIR IMP. DISTAL
Published
2022-06-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTNWASHER, BOLT NUT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTNWasher, Bolt NutOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867340176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867340176008888673401768888673401760888867340176

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation suture buttonA small, implantable device designed to retain the loop of a ligature/suture to provide additional stability and accurate fixation during orthopaedic procedures, typically internal fixation of fractures with or without additional fixation devices (e.g., bone plates, screws). It can be of various shapes (e.g., H-shaped, round, oblong), made of non-bioabsorbable metallic materials [e.g., titanium (Ti)] and is typically implanted with dedicated implantation instruments; it may be supplied with associated sutures/ligatures.

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
00888867614956Arthrex®AR-S8457EXCAR-S8457EXC2026-05-25
00888867531949Arthrex®AR-8827H-22SAR-8827H-22S2026-03-16
00888867531970Arthrex®AR-8827H-28SAR-8827H-28S2026-03-16
00888867531987Arthrex®AR-8827H-30SAR-8827H-30S2026-03-16
00888867532014Arthrex®AR-8827H-36SAR-8827H-36S2026-03-16
00888867134874Arthrex®AR-9104-04AR-9104-042017-02-15
00888867336506Arthrex®AR-1593-4AR-1593-42019-12-13
00888867336520Arthrex®AR-1593DAR-1593D2019-12-13
00888867310209Arthrex®AR-4158TAR-4158T2019-11-15
00888867340183Arthrex®AR-D8400EXAR-D8400EX2019-10-06
00888867504288Arthrex®AR-9953AR-05AR-9953AR-052026-05-21
00888867504295Arthrex®AR-9953AR-03AR-9953AR-032026-05-21
00888867504318Arthrex®AR-9953AR-07AR-9953AR-072026-05-21
00888867504356Arthrex®AR-9953AR-09AR-9953AR-092026-05-21
00888867504363Arthrex®AR-9953AR-11AR-9953AR-112026-05-21
00888867504387Arthrex®AR-9953AR-13AR-9953AR-132026-05-21
00888867504394Arthrex®AR-9953AL-13AR-9953AL-132026-05-21
00888867504400Arthrex®AR-9953AR-15AR-9953AR-152026-05-21
00888867504417Arthrex®AR-9953AL-15AR-9953AL-152026-05-21
00888867504424Arthrex®AR-9953AR-03SAR-9953AR-03S2026-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327075830ASNISStryker GmbHHTN2015-11-11
07613327076189ASNISStryker GmbHHTN2015-11-11
07613327076301ASNISStryker GmbHHTN2015-11-11
07613327076554ASNISStryker GmbHHTN2015-11-11
07613327076721ASNISStryker GmbHHTN2015-11-11
07613327076929ASNISStryker GmbHHTN2015-11-11
07613327077049ASNISStryker GmbHHTN2015-11-11
07613327077308ASNISStryker GmbHHTN2015-11-11
07613327077315ASNISStryker GmbHHTN2015-11-11
07613327077346ASNISStryker GmbHHTN2015-11-11
07613327077391ASNISStryker GmbHHTN2015-11-11
07613327073737VARIAXStryker GmbHHTN2015-09-30
07613327073768VARIAXStryker GmbHHTN2015-09-30
07613327073799VARIAXStryker GmbHHTN2015-09-30
07613327073812VARIAXStryker GmbHHTN2015-09-30
07613327073843VARIAXStryker GmbHHTN2015-09-30
07613327073881VARIAXStryker GmbHHTN2015-09-30
07613327073904VARIAXStryker GmbHHTN2015-09-30
07613327073935VARIAXStryker GmbHHTN2015-09-30
07613327073973VARIAXStryker GmbHHTN2015-09-30
07613327073997VARIAXStryker GmbHHTN2015-09-30
07613327074031VARIAXStryker GmbHHTN2015-09-30
07613327074079VARIAXStryker GmbHHTN2015-09-30
07613327074093VARIAXStryker GmbHHTN2015-09-30
07613327074130VARIAXStryker GmbHHTN2015-09-30
07613327074147VARIAXStryker GmbHHTN2015-09-30
07613327074178VARIAXStryker GmbHHTN2015-09-30
07613327074208VARIAXStryker GmbHHTN2015-09-30
07613327074215VARIAXStryker GmbHHTN2015-09-30
07613327074239VARIAXStryker GmbHHTN2015-09-30