FDA.reportPublic FDA data

KINCISE™ System Acetabular Cup Extraction Bolt

Primary DI
08720254007014
Brand
KINCISE™ System Acetabular Cup Extraction Bolt
Company
Spierings Orthopaedics B.V.
Model
KIN-2110-04
Catalog number
200005015
Published
2024-03-19
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
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
08720254007014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720254007014087202540070148720254007014

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic instrument surgical connectorA small device designed to be used during a surgical procedure to make a physical connection between two orthopaedic instruments, instrument components, or an orthopaedic instrument and another device (e.g., an implant) to facilitate the insertion and placement of implantable devices (e.g., pins, nails, screws, blades) into bone or to achieve a procedure goal (e.g., bone fracture compression). It is typically made of metal and in one of several forms (e.g., screw, nut, threaded rod). 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
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
08720254007076KINCISE™ System Acetabular Cup Extraction SST Head 28mmKIN-2110-28-SS2000050282024-03-19

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