FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867390324
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-1001-TH-PWR
Catalog number
AR-1001-TH-PWR
Device description
Threaded BMA Adapter
Published
2021-10-12
Public version status
New
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
LXIGuide, drill, ligament

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXIGuide, Drill, LigamentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867390324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867390324008888673903248888673903240888867390324

GMDN Terms#

Term, Definition table
TermDefinition
Drilling power tool attachment, basicA device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a drilling function when an appropriate drill bit is inserted. It may include integral design features, e.g., have an angled head, be cannulated, have an attached Jacobs chuck, or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. 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
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
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
G453332321055BC010PEAK MEDICALPeak Medical Distribution Inc.LXI2026-05-06
00888867500884Arthrex®ARTHREX, INC.LXI2026-03-13
00888867500907Arthrex®ARTHREX, INC.LXI2026-03-13
00888867500938Arthrex®ARTHREX, INC.LXI2026-03-13
00888867500976Arthrex®ARTHREX, INC.LXI2026-03-13
00888867500990Arthrex®ARTHREX, INC.LXI2026-03-13
00840124521018PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-06-24
00840124519978PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124519985PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520189PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520226PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520233PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520257PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520264PolyLock AnkleFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520325PolyLock AnkleFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520332PolyLock AnkleFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124519572PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519589PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519602PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519619PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519664PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519671PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519688PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519695PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519701PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519732PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519787PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519794PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519800PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519831PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15