Instrument kit

Primary DI
08054752864139
Brand
Instrument kit
Company
ADLER ORTHO SPA
Model
KZ11006
Catalog number
KZ11006
Device description
(GP6) GENUS PANTHEON TIBIAL PREP
Published
2025-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08054752864139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08054752864139080547528641398054752864139

GMDN Terms#

Term, Definition table
TermDefinition
Joint prosthesis implantation kit, reusableA collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
338847291
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08052693621545Tibial ImpactorKP07340KP073402025-11-03
08052693621552Femoral ImpactorKP07350KP073502025-11-03
08053617185211PunchKZ03312KZ033122025-10-08
08053617185228PunchKZ03334KZ033342025-10-08
08053617185235PunchKZ03356KZ033562025-10-08
08056269043618Trial Tibial AugmentKZ00507KZ005072025-11-03
08056269043625Trial Tibial AugmentKZ00527KZ005272025-11-03
08056269044080Trial Tibial AugmentKZ00501KZ005012025-11-03
08056269044097Trial Tibial AugmentKZ00502KZ005022025-11-03
08056269044103Trial Tibial AugmentKZ00503KZ005032025-11-03
08056269044110Trial Tibial AugmentKZ00504KZ005042025-11-03
08056269044127Trial Tibial AugmentKZ00505KZ005052025-11-03
08056269044134Trial Tibial AugmentKZ00506KZ005062025-11-03
08056269044141Trial Tibial AugmentKZ00521KZ005212025-11-03
08056269044158Trial Tibial AugmentKZ00522KZ005222025-11-03
08056269044165Trial Tibial AugmentKZ00523KZ005232025-11-03
08056269044172Trial Tibial AugmentKZ00524KZ005242025-11-03
08056269044189Trial Tibial AugmentKZ00525KZ005252025-11-03
08056269044196Trial Tibial AugmentKZ00526KZ005262025-11-03
08056269044202Trial Tibial AugmentKZ01001KZ010012025-11-03