FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867095366
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-1588BTB-J
Catalog number
AR-1588BTB-J
Device description
BTB TIGHTROPE W/ DEPLOYING SUTURE
Published
2017-02-15
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
HTYPIN, FIXATION, SMOOTH
MBIFastener, fixation, nondegradable, soft tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867095366PrimaryGS10
M150AR1588BTBJ1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867095366008888670953668888670953660888867095366

GMDN Terms#

Term, Definition table
TermDefinition
Ligament reconstruction instrument set, reusableA collection of surgical instruments intended to be used to prepare a joint for the reconstruction of damaged or torn ligaments, using a replacement device or tissue graft, during open or arthroscopic orthopaedic surgery. It typically consists of one or more guides, carriages, drill bits, reamers, burs, pushers, introducers, a staple impactor, and a surgical hammer. The set may be designed for specific joints, such as the shoulder or knee, and may assist in aligning the bone tunnels to allow isometric implantation of the ligament replacement device or graft. This is a reusable 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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867417229Arthrex®AR-9096A-14-30LAR-9096A-14-30L2026-07-22
00888867417236Arthrex®AR-9096A-14-30RAR-9096A-14-30R2026-07-22
00888867417250Arthrex®AR-9096A-14-32LAR-9096A-14-32L2026-07-22
00888867417274Arthrex®AR-9096A-14-32RAR-9096A-14-32R2026-07-22
00888867417281Arthrex®AR-9096A-14-34LAR-9096A-14-34L2026-07-22
00888867417298Arthrex®AR-9096A-14-34RAR-9096A-14-34R2026-07-22
00888867417304Arthrex®AR-9096A-14-36LAR-9096A-14-36L2026-07-22
00888867417311Arthrex®AR-9096A-14-36RAR-9096A-14-36R2026-07-22
00888867417328Arthrex®AR-9096A-14-38LAR-9096A-14-38L2026-07-22
00888867417335Arthrex®AR-9096A-14-38RAR-9096A-14-38R2026-07-22
00888867417342Arthrex®AR-9096A-14-40LAR-9096A-14-40L2026-07-22
00888867417359Arthrex®AR-9096A-14-40RAR-9096A-14-40R2026-07-22
00888867417366Arthrex®AR-9096A-14-42LAR-9096A-14-42L2026-07-22
00888867417373Arthrex®AR-9096A-14-42RAR-9096A-14-42R2026-07-22
00888867417380Arthrex®AR-9096A-14-44LAR-9096A-14-44L2026-07-22
00888867417397Arthrex®AR-9096A-14-44RAR-9096A-14-44R2026-07-22
00888867417403Arthrex®AR-9096A-14-46LAR-9096A-14-46L2026-07-22
00888867417410Arthrex®AR-9096A-14-46RAR-9096A-14-46R2026-07-22
00888867280502Arthrex®ABS-4080DABS-4080D2018-06-22
00888867084032Arthrex®ABS-10067ABS-100672017-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776403928MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776403935MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436025MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436032MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436049MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436056MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436063MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436070MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436087MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436094MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436100MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436117MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436124MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436131MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436148MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776403775MillenniumAvalign Technologies, Inc.HTY2026-07-21
00190776403850MillenniumAvalign Technologies, Inc.HTY2026-07-21
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