FDA.reportPublic FDA data

Fusion Taper Sleeve -4mm

Primary DI
09348215025830
Brand
Fusion Taper Sleeve -4mm
Company
SIGNATURE ORTHOPAEDICS PTY LTD
Model
111-37-0001
Published
2021-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, PorousOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201047000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201047000Fusion Taper SystemSignature Orthopaedics Pty, Ltd.2021-04-16LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348215025830PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348215025830093482150258309348215025830

GMDN Terms#

Term, Definition table
TermDefinition
Femoral head/stem prosthesis adaptorA sterile implantable tubular device designed to connect a femoral head prosthesis to the trunnion of a femoral stem prosthesis. It is typically intended to be used as part of a total hip arthroplasty (THA) revision to correct offset, neck length, lateralization, and anteversion/retroversion where there is a good fitting stem; it may also be used as part of a primary procedure. It is made of metal [e.g., titanium (Ti) alloy] and is available in various sizes and shapes; it is intended to be used with a dedicated femoral head prosthesis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
751993028
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09348215185428Signature Magnum Acetabular Cup111-67-00442026-07-29
09348215185435Signature Magnum Acetabular Cup111-67-00462026-07-29
09348215185442Signature Magnum Acetabular Cup111-67-00482026-07-29
09348215185459Signature Magnum Acetabular Cup111-67-00502026-07-29
09348215185466Signature Magnum Acetabular Cup111-67-00522026-07-29
09348215185473Signature Magnum Acetabular Cup111-67-00542026-07-29
09348215185480Signature Magnum Acetabular Cup111-67-00562026-07-29
09348215185497Signature Magnum Acetabular Cup111-67-00582026-07-29
09348215185503Signature Magnum Acetabular Cup111-67-00602026-07-29
09348215185510Signature Magnum Acetabular Cup111-67-00622026-07-29
09348215185527Signature Magnum Acetabular Cup111-67-00642026-07-29
09348215185534Signature Magnum Acetabular Cup111-67-00662026-07-29
09348215185541Signature Resurfacing Femoral Head111-67-01382026-07-29
09348215185558Signature Resurfacing Femoral Head111-67-01402026-07-29
09348215185565Signature Resurfacing Femoral Head111-67-01422026-07-29
09348215185572Signature Resurfacing Femoral Head111-67-01442026-07-29
09348215185589Signature Resurfacing Femoral Head111-67-01462026-07-29
09348215185596Signature Resurfacing Femoral Head111-67-01482026-07-29
09348215185602Signature Resurfacing Femoral Head111-67-01502026-07-29
09348215185619Signature Resurfacing Femoral Head111-67-01522026-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630542796555Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796562Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796579Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796586Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796593Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796609Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796616Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796623Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796630Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796647Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796654Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796661Mfinity Femoral SystemMedacta International SAMEH2026-08-25
05056139247293Icona Hip StemCORIN LTDMEH2025-04-07
05056139247293Icona Hip StemCORIN LTDLZO2025-04-07
10885862022448NAExactech, Inc.MEH2022-09-19
10885862022448NAExactech, Inc.LZO2022-09-19
10885862022455NAExactech, Inc.LZO2022-09-19
10885862022455NAExactech, Inc.MEH2022-09-19
10885862029867NAExactech, Inc.LZO2022-09-19
10885862034038NovationExactech, Inc.LZO2022-09-19
10885862034038NovationExactech, Inc.MEH2022-09-19
10885862034045NovationExactech, Inc.MEH2022-09-19
10885862034045NovationExactech, Inc.LZO2022-09-19
10885862034052NovationExactech, Inc.MEH2022-09-19
10885862034052NovationExactech, Inc.LZO2022-09-19
10885862034069NovationExactech, Inc.LZO2022-09-19
10885862034069NovationExactech, Inc.MEH2022-09-19
10885862034076NovationExactech, Inc.LZO2022-09-19
10885862034076NovationExactech, Inc.MEH2022-09-19
10885862034083NovationExactech, Inc.LZO2022-09-19