FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867026599
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-2270
Catalog number
AR-2270
Device description
BUTTON, DOG BONE
Published
2017-02-15
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
GATSuture, nonabsorbable, synthetic, polyethylene
HTNWASHER, BOLT NUT
HWCScrew, fixation, bone
JDQCerclage, fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2
HTNWasher, Bolt NutOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2
JDQCerclage, FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867026599PrimaryGS10
M150AR22701SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867026599008888670265998888670265990888867026599

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.

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
00888867498105Arthrex®AR-3210-0037AR-3210-00372026-07-31
00888867532236Arthrex®AR-S7500-030-260-SAR-S7500-030-260-S2026-07-31
00888867532243Arthrex®AR-S7500-030-360-SAR-S7500-030-360-S2026-07-31
00888867532250Arthrex®AR-S7500-040-260-SAR-S7500-040-260-S2026-07-31
00888867532267Arthrex®AR-S7500-040-360-SAR-S7500-040-360-S2026-07-31
00888867532274Arthrex®AR-S7500-050-260-SAR-S7500-050-260-S2026-07-31
00888867544819Arthrex®AR-S7510-030-260AR-S7510-030-2602026-07-31
00888867544826Arthrex®AR-S7510-040-260AR-S7510-040-2602026-07-31
00888867544833Arthrex®AR-S7510-050-260AR-S7510-050-2602026-07-31
00888867544840Arthrex®AR-S7563-030-260AR-S7563-030-2602026-07-31
00888867544857Arthrex®AR-S7563-030-360AR-S7563-030-3602026-07-31
00888867544864Arthrex®AR-S7570-030-260AR-S7570-030-2602026-07-31
00888867544871Arthrex®AR-S7570-030-360AR-S7570-030-3602026-07-31
00888867544888Arthrex®AR-S7570-040-260AR-S7570-040-2602026-07-31
00888867544895Arthrex®AR-S7570-040-360AR-S7570-040-3602026-07-31
00888867572010Arthrex®AR-S7500-000-000WAR-S7500-000-000W2026-07-31
00888867572034Arthrex®AR-S7500-100-000WAR-S7500-100-000W2026-07-31
00888867572041Arthrex®AR-S7500-100-000FAR-S7500-100-000F2026-07-31
00888867571129Arthrex®ABS-1981-20SABS-1981-20S2026-07-29
00888867020498Arthrex®AR-1648AR-16482018-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00688346003918Fine TTOLaboratoires Bodycad IncHWC2026-08-03
00688346005356Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHWC2026-08-03
00688346005387Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHWC2026-08-03
00688346005523Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHWC2026-08-03
00688346005554Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHWC2026-08-03
00860007711251EasyWhipWinter Innovations Inc.GAT2026-08-01
00860007711275EasyWhipWinter Innovations Inc.GAT2026-08-01
00860014630712EasyWhipWinter Innovations Inc.GAT2026-08-01
00860014630743EasyWhipWinter Innovations Inc.GAT2026-08-01
00860014630750EasyWhipWinter Innovations Inc.GAT2026-08-01
00860014630767EasyWhipWinter Innovations Inc.GAT2026-08-01
14026704724441DEKNATELTELEFLEX INCORPORATEDGAT2026-08-01
14026704724861DEKNATELTELEFLEX INCORPORATEDGAT2026-08-01
14026704725042DEKNATELTELEFLEX INCORPORATEDGAT2026-08-01
07899258606637Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606644Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606651Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606668Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606675Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606682Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606699Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606705Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606712Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606729Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606736Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606743Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606750Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606767Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606774Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606781Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30