FDA.reportPublic FDA data

Tibial IM Cut Adaptor

Primary DI
09348215046217
Brand
Tibial IM Cut Adaptor
Company
SIGNATURE ORTHOPAEDICS PTY LTD
Model
122-16-0070
Published
2019-02-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181338000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181338000Imboki Knee Instrument SystemSignature Orthopaedics Pty, Ltd.2019-01-17JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348215046217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348215046217093482150462179348215046217

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant/instrument adaptor, reusableA connecting device designed to join an implant to a surgical instrument or a surgical instrument to another instrument particularly to create an extension or to connect two devices where the interfaces of the devices are not compatible. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of sizes and lengths. This device can be used, e.g., during a percutaneous interspinous distraction procedure for the removal of a distraction sleeve. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
751993028
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09348215158828World Knee MC Poly Insert - Size 8 - 10mm, Left121-20-7890L2026-06-09
09348215158835World Knee MC Poly Insert - Size 8 - 11mm, Left121-20-7891L2026-06-09
09348215158842World Knee MC Poly Insert - Size 8 - 12mm, Left121-20-7892L2026-06-09
09348215158859World Knee MC Poly Insert - Size 8 - 13mm, Left121-20-7893L2026-06-09
09348215158866World Knee MC Poly Insert - Size 8 - 14mm, Left121-20-7894L2026-06-09
09348215158873World Knee MC Poly Insert - Size 8 - 15mm, Left121-20-7895L2026-06-09
09348215158880World Knee MC Poly Insert - Size 8 - 16mm, Left121-20-7896L2026-06-09
09348215158897World Knee MC Poly Insert - Size 8 - 17mm, Left121-20-7897L2026-06-09
09348215158903World Knee MC Poly Insert - Size 8 - 18mm, Left121-20-7898L2026-06-09
09348215158910World Knee MC Poly Insert - Size 8 - 10mm, Right121-20-7890R2026-06-09
09348215158927World Knee MC Poly Insert - Size 8 - 11mm, Right121-20-7891R2026-06-09
09348215158934World Knee MC Poly Insert - Size 8 - 12mm, Right121-20-7892R2026-06-09
09348215158941World Knee MC Poly Insert - Size 8 - 13mm, Right121-20-7893R2026-06-09
09348215158958World Knee MC Poly Insert - Size 8 - 14mm, Right121-20-7894R2026-06-09
09348215158965World Knee MC Poly Insert - Size 8 - 15mm, Right121-20-7895R2026-06-09
09348215158972World Knee MC Poly Insert - Size 8 - 16mm, Right121-20-7896R2026-06-09
09348215158989World Knee MC Poly Insert - Size 8 - 17mm, Right121-20-7897R2026-06-09
09348215158996World Knee MC Poly Insert - Size 8 - 18mm, Right121-20-7898R2026-06-09
09348215160265World Knee MC Vit-E Poly Insert - Size 7 - 10mm, Left121-20-7790LE2026-06-09
09348215160272World Knee MC Vit-E Poly Insert - Size 7 - 11mm, Left121-20-7791LE2026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091353ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091360ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091377ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091384ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091391ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091407ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091209ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-03
00810130456406Medco ManufacturingMedco Manufacturing LLCMDM2026-06-02
00846338007126Endiscope and accessoriesELLIQUENCE, LLCMDM2026-06-02
00846338005429DilatorELLIQUENCE, LLCMDM2026-06-01
06932503510219Pulmonary Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.MDM2026-05-29
06932503510226Pulmonary Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.MDM2026-05-29
B356KE392100American MedicalsAmerican MedicalsMDM2026-05-29
B356KE396100American MedicalsAmerican MedicalsMDM2026-05-29
08800042700102Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700140Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700256Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700270Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700287Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700300Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700317Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700324Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700386Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700393Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700416Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700423Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700843Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700850Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700874Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700881Artisential Precise Needle HolderLIVSMEDMDM2026-04-29