FDA.reportPublic FDA data

Cup Reamer Size 48

Primary DI
07630055300218
Brand
Cup Reamer Size 48
Company
Incipio Devices SA
Model
3700502206715
Catalog number
3700502206715
Device description
Acetabular reamer ø49mm for implant cup ø48mm
Published
2019-12-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
07630055300218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630055300218076300553002187630055300218

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 Diameter49Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
485098284
Device count
1
Premarket exempt
true
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
07630055307026Offset Reamer Handle - Large AO - Tri coupling922061T502445112026-05-07
07630055307033Offset reamer handle - Tri Coupling Transmission922061T-EZ502445102026-05-07
07630055307736ACE Acetabular Reamer Tray - Instrument Tray50740101507401012026-04-30
07630055306722Offset reamer handle - Dual Coupling90CH.IN.004502445002026-03-17
07630055306739Offset reamer handle - Large AO motor shaft90CH.IN.AO1502445062026-03-17
07630055306746Offset reamer handle - Stryker Z/H motor shaft90CH.IN.ZH1502445072026-03-17
07630055306753Offset reamer handle - Hudson motor shaft90CH.IN.HU1502445082026-03-17
07630055306760Straight reamer handle - large AO - Dual coupling90ST.IN.AO1502445502026-03-17
07630055306777Straight reamer handle -Stryker Z/H - Dual coupling90ST.IN.ZH1502445512026-03-17
07630055306784Straight reamer handle - Hudson - Dual coupling90ST.IN.HU1502445522026-03-17
07630055306791Offset reamer handle - Dual coupling131-174/05502445002026-03-10
07630055306807Offset reamer handle - Handle131-174/01502445042026-03-10
07630055306814Offset reamer handle - Body131-174/02502445052026-03-10
07630055306821Offset reamer handle - Dual Coupling transmission131-174/03502445092026-03-10
07630055306838Offset reamer handle - Large AO motor shaft131-174/04D502445062026-03-10
07630055306845Offset reamer handle - Stryker Z/H motor shaft131-174/04H502445072026-03-10
07630055306852Offset reamer handle - Hudson motor shaft131-174/04B502445082026-03-10
07630055306869Straight reamer handle - Jacobs - Dual coupling131-171E502445492026-03-10
07630055306876Straight reamer handle - large AO - Dual coupling131-171D502445502026-03-10
07630055306883Straight reamer handle -Stryker Z/H - Dual coupling131-171H502445512026-03-10

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