FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867089006
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-13315-1
Catalog number
AR-13315-1
Device description
HTO HINGE PIN
Published
2018-06-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867089006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867089006008888670890068888670890060888867089006

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
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
00888867561687Arthrex®AR-2600FSF-1AR-2600FSF-12026-03-17
00888867561694Arthrex®AR-2600FSF-2AR-2600FSF-22026-03-17
00888867561700Arthrex®AR-2600FSF-3AR-2600FSF-32026-03-17
00888867463363Arthrex®AR-8974-02AR-8974-022026-03-16
00888867519459Arthrex®AR-8974FCAR-8974FC2026-03-16
00888867519473Arthrex®AR-8974FCLAR-8974FCL2026-03-16
00888867519503Arthrex®AR-8974TAR-8974T2026-03-16
00888867519510Arthrex®AR-8974TLAR-8974TL2026-03-16
00888867529038Arthrex®AR-8827H-10AR-8827H-102026-03-16
00888867529045Arthrex®AR-8827H-12AR-8827H-122026-03-16
00888867529052Arthrex®AR-8827H-14AR-8827H-142026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810111227148K-WireTreace Medical Concepts, Inc.HWE2026-03-23
10885862661555N/AExactech, Inc.HWE2026-03-19
00888867529762Arthrex®ARTHREX, INC.HWE2026-03-16
00888867529779Arthrex®ARTHREX, INC.HWE2026-03-16
00888867529809Arthrex®ARTHREX, INC.HWE2026-03-16
00888867529830Arthrex®ARTHREX, INC.HWE2026-03-16
00888867529847Arthrex®ARTHREX, INC.HWE2026-03-16
00888867531628Arthrex®ARTHREX, INC.HWE2026-03-16
00888867531635Arthrex®ARTHREX, INC.HWE2026-03-16
00888867531680Arthrex®ARTHREX, INC.HWE2026-03-16
00888867531727Arthrex®ARTHREX, INC.HWE2026-03-16
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09421038412183Handle – UnitedENZTEC LIMITEDHWE2026-03-09
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00810111225601ReamerTreace Medical Concepts, Inc.HWE2026-03-02
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09421038412725Enztec Reamer 36mm - BridgebackENZTEC LIMITEDHWE2026-02-23