FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867529601
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-8974-01R
Catalog number
AR-8974-01R
Device description
FibuLock® PRO Targeting Guide, Right
Published
2026-03-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
HTNWASHER, BOLT NUT
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2
HTNWasher, Bolt NutOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867529601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867529601008888675296018888675296010888867529601

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant aiming armA surgical jig-like device designed as a precision guide for the pre-drilling of orthopaedic screw holes into bone and for guiding an orthopaedic instrument into an implanted device, typically to treat long bones (e.g., femur, humerus, and tibia). It typically consists of two parts in one-piece or modular configurations: 1) an insertion guide in which the correctly angled/placed guide holes are situated; and 2) an insertion handle which will attach to the bone or implant. Drill guides or other drilling/tapping devices will be fed through the insertion guide at the precise intended angle, and it may have adaptations for providing magnetic alignment. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
131747628
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867007482Arthrex®AR-13100-05.0SAR-13100-05.0S2017-01-20
00888867007529Arthrex®AR-13100-09.0SAR-13100-09.0S2017-01-20
00888867007567Arthrex®AR-13100-11.0SAR-13100-11.0S2017-01-20
00888867007604Arthrex®AR-13100-15.0SAR-13100-15.0S2017-01-20
00888867007628Arthrex®AR-13100-17.5SAR-13100-17.5S2017-01-20
00888867008564Arthrex®AR-13200-03.0SAR-13200-03.0S2017-01-20
00888867204041Arthrex®AR-8952XLSAR-8952XLS2017-07-18
00888867210424Arthrex®AR-8933L-26SAR-8933L-26S2017-08-31
00888867210431Arthrex®AR-8933L-28SAR-8933L-28S2017-08-31
00888867210448Arthrex®AR-8933L-30SAR-8933L-30S2017-08-31
00888867210462Arthrex®AR-8933L-34SAR-8933L-34S2017-08-31
00888867210479Arthrex®AR-8933L-36SAR-8933L-36S2017-08-31
00888867210493Arthrex®AR-8933L-40SAR-8933L-40S2017-08-31
00888867251960Arthrex®AR-8958-01SAR-8958-01S2017-11-28
00888867266872Arthrex®AR-8952PPLAR-8952PPL2017-03-28
00888867266896Arthrex®AR-8952PSRAR-8952PSR2017-03-28
00888867266957Arthrex®AR-8952PPRAR-8952PPR2017-03-28
00888867371828Arthrex®AR-8924SAR-8924S2023-05-25
00888867251939Arthrex®AR-8958-02AR-8958-022017-02-15
00888867279285Arthrex®AR-7249-12-1AR-7249-12-12017-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700569658212Xpert PFPNEWCLIP TECHNICSHWC2026-06-03
00842188131981CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188131998CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132001CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132018CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132025CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132032CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132049CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132056CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132063Tools - HCSTrimed, INC.HWC2026-06-02
00842188132070Tools - HCSTrimed, INC.HWC2026-06-02
00850080543009PC Fix Locking Post TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543016PC Fix Locking Cap TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543023PC Fix Washer TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543030PC Fix Extrathoracic Plate 70mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543047PC Fix Extrathoracic Plate 95mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543054PC Fix Intrathoracic Plate 70mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543061PC Fix Intrathoracic Plate 95mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543078PC Fix Thoracic Plate 70mm PEEKChest Wall Innovations, Inc.HTN2026-06-01
00850080543085PC Fix Thoracic Plate 95mm PEEKChest Wall Innovations, Inc.HTN2026-06-01
00850080543092PC Fix 3.2mm Drill Brad Point QCChest Wall Innovations, Inc.HTN2026-06-01
00850080543108PC Fix Graphic CaseChest Wall Innovations, Inc.HTN2026-06-01
00850080543115PC Fix Clamp/Drill Guide TopChest Wall Innovations, Inc.HTN2026-06-01
00850080543122PC Fix Clamp/Drill Guide BottomChest Wall Innovations, Inc.HTN2026-06-01
00850080543139PC Fix Compression ClampChest Wall Innovations, Inc.HTN2026-06-01
00850080543146PC Fix 3.2mm Drill Dental LatchChest Wall Innovations, Inc.HTN2026-06-01
00850080543184PC Fix Implant CaddyChest Wall Innovations, Inc.HTN2026-06-01
07630894829819APTUSMedartis AGHWC2026-06-01
07630894829826APTUSMedartis AGHWC2026-06-01
07630894829833APTUSMedartis AGHWC2026-06-01