KINCISE™ System Acetabular Cup Extraction Finisher Blade 46mm 200005246

GUDID 08720254007489

Spierings Orthopaedics B.V.

Orthopaedic osteotome blade, single-use
Primary Device ID08720254007489
NIH Device Record Key489a1c0d-2a8e-4469-8675-516f22206b49
Commercial Distribution StatusIn Commercial Distribution
Brand NameKINCISE™ System Acetabular Cup Extraction Finisher Blade 46mm
Version Model NumberKIN-2110-46F-SU
Catalog Number200005246
Company DUNS407288690
Company NameSpierings Orthopaedics B.V.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108720254007489 [Primary]

FDA Product Code

HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08720254007489]

Moist Heat or Steam Sterilization


[08720254007489]

Moist Heat or Steam Sterilization


[08720254007489]

Moist Heat or Steam Sterilization


[08720254007489]

Moist Heat or Steam Sterilization


[08720254007489]

Moist Heat or Steam Sterilization


[08720254007489]

Moist Heat or Steam Sterilization


[08720254007489]

Moist Heat or Steam Sterilization


[08720254007489]

Moist Heat or Steam Sterilization


[08720254007489]

Moist Heat or Steam Sterilization


[08720254007489]

Moist Heat or Steam Sterilization


[08720254007489]

Moist Heat or Steam Sterilization


[08720254007489]

Moist Heat or Steam Sterilization


[08720254007489]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-28
Device Publish Date2024-03-20

Devices Manufactured by Spierings Orthopaedics B.V.

08720828234181 - KINCISE™ System Acetabular Cup Extraction Case Standard Set2024-04-03
08720828234198 - KINCISE™ System Acetabular Cup Extraction Case Outlier Set2024-04-03
08720254007472 - KINCISE™ System Acetabular Cup Extraction Finisher Blade 44mm2024-03-28
08720254007489 - KINCISE™ System Acetabular Cup Extraction Finisher Blade 46mm2024-03-28
08720254007489 - KINCISE™ System Acetabular Cup Extraction Finisher Blade 46mm2024-03-28
08720254007496 - KINCISE™ System Acetabular Cup Extraction Finisher Blade 48mm2024-03-28
08720254007502 - KINCISE™ System Acetabular Cup Extraction Finisher Blade 50mm2024-03-28
08720254007519 - KINCISE™ System Acetabular Cup Extraction Finisher Blade 52mm2024-03-28
08720254007526 - KINCISE™ System Acetabular Cup Extraction Finisher Blade 54mm2024-03-28

Trademark Results [KINCISE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
KINCISE
KINCISE
90105877 not registered Live/Pending
Depuy Synthes, Inc.
2020-08-11
KINCISE
KINCISE
88032292 not registered Live/Pending
Depuy Synthes, Inc.
2018-07-10

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.