FDA.reportPublic FDA data

Fusion Taper Sleeve +6mm

Primary DI
09348215062163
Brand
Fusion Taper Sleeve +6mm
Company
SIGNATURE ORTHOPAEDICS PTY LTD
Model
111-37-0008
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
09348215062163PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348215062163093482150621639348215062163

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
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
07630542788314AMIStem-PMedacta International SALZO2026-06-08
07630542788321AMIStem-PMedacta International SALZO2026-06-08
07630542788338AMIStem-PMedacta International SALZO2026-06-08
07630542788345AMIStem-PMedacta International SALZO2026-06-08
07630542788352AMIStem-PMedacta International SALZO2026-06-08
07630542788369AMIStem-PMedacta International SALZO2026-06-08
07630542788376AMIStem-PMedacta International SALZO2026-06-08
00810030811992InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812036InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812043InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812050InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812067InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812074InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812081InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812098InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812104InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812111InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812128InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812135InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812142InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812159InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812173InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812180InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812197InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812203InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812210InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812227InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812234InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812241InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812258InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01