FDA.reportPublic FDA data

Acetabular reamer ø48mm

Primary DI
07630055301024
Brand
Acetabular reamer ø48mm
Company
Incipio Devices SA
Model
50142048
Catalog number
50142048
Device description
Acetabular reamer ø48mm
Published
2019-12-06
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
07630055301024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630055301024076300553010247630055301024

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 Diameter48Millimeter

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
07630055307781Positioning handle - M8x1 interface75.70.05775.70.0572026-07-16
07630055307798Positioning handle - M10x1.5 interface75.70.05975.70.0592026-07-16
07630055307804Offset Cup Impactor - M8x1 interface01.15.10.055601.15.10.05562026-07-16
07630055307811Offset Cup Impactor - M10x1.5 interface01.15.10.055501.15.10.05552026-07-16
07630055302458Offset Cup Impactor - M8x1 interface01.15.10.055601.15.10.05562020-04-23
07630055302465Offset Cup Impactor - M10x1.5 interface01.15.10.055501.15.10.05552020-04-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B356JB405140American MedicalsAmerican MedicalsHTO2026-07-06
00889024701502Identity® Shoulder SystemZimmer, Inc.HTO2026-06-10
00889024701519Identity® Shoulder SystemZimmer, Inc.HTO2026-06-10
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