FDA.reportPublic FDA data

Cemented TSI Stem System

Primary DI
09348215031503
Brand
Cemented TSI Stem System
Company
SIGNATURE ORTHOPAEDICS PTY LTD
Model
111-34-1003
Published
2019-02-22
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
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181340000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181340000Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.2019-02-11JDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348215031503PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348215031503093482150315039348215031503

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated femoral stem prosthesis, one-pieceA sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is one-piece, is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is not coated with materials intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation is intended to be performed with bone cement.

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

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