FDA.reportPublic FDA data

LexTOME

Primary DI
04589761815475
Brand
LexTOME
Company
MEDMETALEX CO., LTD.
Model
MUA00015
Catalog number
MUA00015
Device description
ACETABULAR REAMER 50mm
Published
2023-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HTOReamer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04589761815475PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04589761815475045897618154754589761815475

GMDN Terms#

Term, Definition table
TermDefinition
Acetabular orthopaedic reamerAn orthopaedic surgical instrument designed to cut and resurface with precision the acetabulum for the acceptance of the acetabular component of a hip joint prosthesis. The device is designed with a hemispherical shell with an abrasive outer surface as the cutting head that is attached to a shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy and is available in various sizes. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter50Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
718085432
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04589761815826LexCALIPERMUA00050MUA000502023-03-31
04589761818001LexTORNADOMUA00051MUA000512023-10-02
04589761818018LexTORNADOMUA00052MUA000522023-10-02
04589761815789LexTOMEMUA00046MUA000462023-04-24
04589761818025LexBLADEMUA00053MUA000532023-10-02
04589761818032LexBLADEMUA00054MUA000542023-10-02
04589761818049LexBLADEMUA00055MUA000552023-10-02
04589761818056LexBLADEMUA00056MUA000562023-10-02
04589761818063LexBLADEMUA00057MUA000572023-10-02
04589761818070LexBLADEMUA00058MUA000582023-10-02
04589761818087LexBLADEMUA00059MUA000592023-10-02
04589761818094LexBLADEMUA00060MUA000602023-10-02
04589761818100LexBLADEMUA00061MUA000612023-10-02
04589761818117LexBLADEMUA00062MUA000622023-10-02
04589761818124LexBLADEMUA00063MUA000632023-10-02
04589761818131LexBLADEMUA00064MUA000642023-10-02
04589761818346quick armMUA00065MUA000652023-10-02
04589761818353quick armMUA00066MUA000662023-10-02
04589761818360quick armMUA00067MUA000672023-10-02
04589761818377quick armMUA00068MUA000682023-10-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810094692797Tibial Reamer, Square Tip, Klassic ONE 25/50mmTOTAL JOINT ORTHOPEDICS, INC.HTO2026-06-09
00810030810575InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810582InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810599InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810605InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810612InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810629InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810636InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810643InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810650InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810667InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810674InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810681InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810698InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810704InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810414InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810421InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810438InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810445InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810452InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810469InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810476InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810483InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810490InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810506InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810513InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810520InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810537InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810544InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810551InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31