Spartan Stem

GUDID 09348215093921

SIGNATURE ORTHOPAEDICS PTY LTD

Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular

Primary Device ID	09348215093921
NIH Device Record Key	29d24f60-c76b-49bf-bc52-73b9f9a3f576
Commercial Distribution Status	In Commercial Distribution
Brand Name	Spartan Stem
Version Model Number	01-050-01-0103
Company DUNS	751993028
Company Name	SIGNATURE ORTHOPAEDICS PTY LTD
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09348215093921 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K192883

FDA Product Code

LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-03-18
Device Publish Date	2022-03-10

On-Brand Devices [Spartan Stem]

09348215094010	01-050-01-0112
09348215094003	01-050-01-0111
09348215093990	01-050-01-0110
09348215093983	01-050-01-0109
09348215093976	01-050-01-0108
09348215093969	01-050-01-0107
09348215093952	01-050-01-0106
09348215093945	01-050-01-0105
09348215093938	01-050-01-0104
09348215093921	01-050-01-0103
09348215093914	01-050-01-0102
09348215093907	01-050-01-0012
09348215093891	01-050-01-0011
09348215093884	01-050-01-0010
09348215093877	01-050-01-0009
09348215093860	01-050-01-0008
09348215093853	01-050-01-0007
09348215093846	01-050-01-0006
09348215093839	01-050-01-0005
09348215093822	01-050-01-0004
09348215093815	01-050-01-0003
09348215093808	01-050-01-0002
09348215093792	01-050-01-0212
09348215093785	01-050-01-0211
09348215093778	01-050-01-0210
09348215093761	01-050-01-0209
09348215093754	01-050-01-0208
09348215093747	01-050-01-0207
09348215093730	01-050-01-0206
09348215093723	01-050-01-0205
09348215093716	01-050-01-0204
09348215093709	01-050-01-0203
09348215093693	01-050-01-0202