FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867373976
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-7820
Catalog number
AR-7820
Device description
Disposable Cerclage Tensioner
Published
2021-12-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867373976PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867373976008888673739768888673739760888867373976

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic graft tensioner, single-useA sterile, hand-held, manual surgical instrument intended to be used during an open-surgery procedure [e.g., acromioclavicular joint repair, anterior cruciate ligament (ACL) reconstruction] to apply appropriate tension to a ligament graft/prosthesis, or flexible cord, to remove slack and facilitate adequate positioning of the device during implantation; it may also be used to apply tension to flexible instruments used during the procedure (e.g., graft sizer or gauge). Tension is applied to the graft after one end of the graft has been secured. The device is typically made of metal and in the form of a shaft with distal prongs. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)934-4404complaints@arthrex.com

Regulatory Flags#

DUNS number
131747628
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867620964Arthrex®AR-3210-0067AR-3210-00672026-10-12
00888867620971Arthrex®AR-3210-0067-PKAR-3210-0067-PK2026-10-12
00888867620988Arthrex®AR-3210-0068AR-3210-00682026-10-12
00888867620995Arthrex®AR-3210-0068-PKAR-3210-0068-PK2026-10-12
00888867520745Arthrex®AR-1360FT-KFTAR-1360FT-KFT2026-01-21
00888867429857Arthrex®AR-2600FSB-1AR-2600FSB-12023-05-24
00888867429864Arthrex®AR-2600FSB-2AR-2600FSB-22023-05-24
00888867429871Arthrex®AR-2600FSB-3AR-2600FSB-32023-05-24
00888867429888Arthrex®AR-2600FSB-4AR-2600FSB-42023-05-24
00888867354067Arthrex®AR-1360FT-BCAR-1360FT-BC2020-12-15
00888867101951Arthrex®AR-3600DCAR-3600DC2018-12-21
00888867096066Arthrex®AR-1677BC-CPAR-1677BC-CP2017-02-15
00888867084384Arthrex®ABS-3005ABS-30052017-02-15
00888867084407Arthrex®ABS-3008ABS-30082017-02-15
00888867084421Arthrex®ABS-3016ABS-30162017-02-15
00888867084148Arthrex®ABS-2001-01ABS-2001-012017-02-15
00888867084155Arthrex®ABS-2001-02ABS-2001-022017-02-15
00888867084162Arthrex®ABS-2001-05ABS-2001-052017-02-15
00888867084179Arthrex®ABS-2001-10ABS-2001-102017-02-15
00888867084186Arthrex®ABS-2002-01ABS-2002-012017-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776434762MillenniumAvalign Technologies, Inc.LXH2026-10-12
00850080243176OSTEOROD Delivery SystemBONE SOLUTIONS, INC.LXH2026-10-12
00889795150264APEX 3D Total Ankle Replacement SystemParagon 28, Inc.LXH2026-10-12
B0842003000000Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000010Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000020Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000030Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000100Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000110Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000120Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000130Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000200Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000210Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000220Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000230Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000300Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000310Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000320Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000330Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000400Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000410Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000420Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000430Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000500Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000510Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000520Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000530Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000600Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000610Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000620Keos Lumbar InstrumentKEOSLXH2023-02-10