FDA.reportPublic FDA data

Inverted Reamer Z-S Hall ø 54

Primary DI
08720256027355
Brand
Inverted Reamer Z-S Hall ø 54
Company
Spierings Orthopaedics B.V.
Model
SBM-1207-56
Published
2023-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08720256027355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720256027355087202560273558720256027355

GMDN Terms#

Term, Definition table
TermDefinition
Bone-resection orthopaedic reamer, reusableAn orthopaedic surgical instrument designed to resect bone (cut out part of the bone) and precisely shape a specific area of bone as it is advanced for the acceptance of a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna). Commonly called a mill or a reamer it is typically designed as either a preshaped or a solid cylindrical body with an end/circumferential cutting edge, and is attached to a shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy in varying sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
407288690
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
08720828234181KINCISE™ System Acetabular Cup Extraction Case Standard SetKIN-2110-062000051002024-03-26
08720828234198KINCISE™ System Acetabular Cup Extraction Case Outlier SetKIN-2110-072000052002024-03-26
08720254007472KINCISE™ System Acetabular Cup Extraction Finisher Blade 44mmKIN-2110-44F-SU2000052442024-03-20
08720254007489KINCISE™ System Acetabular Cup Extraction Finisher Blade 46mmKIN-2110-46F-SU2000052462024-03-20
08720254007496KINCISE™ System Acetabular Cup Extraction Finisher Blade 48mmKIN-2110-48F-SU2000052482024-03-20
08720254007502KINCISE™ System Acetabular Cup Extraction Finisher Blade 50mmKIN-2110-50F-SU2000052502024-03-20
08720254007519KINCISE™ System Acetabular Cup Extraction Finisher Blade 52mmKIN-2110-52F-SU2000052522024-03-20
08720254007526KINCISE™ System Acetabular Cup Extraction Finisher Blade 54mmKIN-2110-54F-SU2000052542024-03-20
08720254007533KINCISE™ System Acetabular Cup Extraction Finisher Blade 56mmKIN-2110-56F-SU2000052562024-03-20
08720254007540KINCISE™ System Acetabular Cup Extraction Finisher Blade 58mmKIN-2110-58F-SU2000052582024-03-20
08720254007557KINCISE™ System Acetabular Cup Extraction Finisher Blade 60mmKIN-2110-60F-SU2000052602024-03-20
08720254007564KINCISE™ System Acetabular Cup Extraction Finisher Blade 62mmKIN-2110-62F-SU2000052622024-03-20
08720254007571KINCISE™ System Acetabular Cup Extraction Finisher Blade 64mmKIN-2110-64F-SU2000052642024-03-20
08720254007588KINCISE™ System Acetabular Cup Extraction Finisher Blade 66mmKIN-2110-66F-SU2000052662024-03-20
08720254007595KINCISE™ System Acetabular Cup Extraction Finisher Blade 68mmKIN-2110-68F-SU2000052682024-03-20
08720254007007KINCISE™ System Acetabular Cup Extraction ShaftKIN-2110-012000050002024-03-19
08720254007014KINCISE™ System Acetabular Cup Extraction BoltKIN-2110-042000050152024-03-19
08720254007021KINCISE™ System Acetabular Cup Extraction Hex KeyKIN-2110-052000050162024-03-19
08720254007038KINCISE™ System Acetabular Cup Extraction WrenchKIN-2110-022000050172024-03-19
08720254007069KINCISE™ System Acetabular Cup Extraction SST Head 26mmKIN-2110-26-SS2000050262024-03-19

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