Spartan Hip Stem

GUDID 09348215058760

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

Primary Device ID	09348215058760
NIH Device Record Key	a8a46d00-fd66-42bc-ae06-ab9a44686fd6
Commercial Distribution Status	In Commercial Distribution
Brand Name	Spartan Hip Stem
Version Model Number	111-44-1203
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	09348215058760 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K192883

FDA Product Code

MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

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	2020-09-09
Device Publish Date	2020-09-01

On-Brand Devices [Spartan Hip Stem]

09348215059033	111-44-1212
09348215059026	111-44-1112
09348215059019	111-44-1012
09348215059002	111-44-1211
09348215058999	111-44-1111
09348215058982	111-44-1011
09348215058975	111-44-1210
09348215058968	111-44-1110
09348215058951	111-44-1010
09348215058944	111-44-1209
09348215058937	111-44-1109
09348215058920	111-44-1009
09348215058913	111-44-1208
09348215058906	111-44-1108
09348215058890	111-44-1008
09348215058883	111-44-1207
09348215058876	111-44-1107
09348215058869	111-44-1007
09348215058852	111-44-1206
09348215058845	111-44-1106
09348215058838	111-44-1006
09348215058821	111-44-1205
09348215058814	111-44-1105
09348215058807	111-44-1005
09348215058791	111-44-1204
09348215058784	111-44-1104
09348215058777	111-44-1004
09348215058760	111-44-1203
09348215058753	111-44-1103
09348215058746	111-44-1003
09348215058678	111-44-0212
09348215058661	111-44-0112
09348215058654	111-44-0012
09348215058647	111-44-0211
09348215058630	111-44-0111
09348215058623	111-44-0011
09348215058616	111-44-0210
09348215058609	111-44-0110
09348215058593	111-44-0010
09348215058586	111-44-0209
09348215058579	111-44-0109
09348215058562	111-44-0009
09348215058555	111-44-0208
09348215058548	111-44-0108
09348215058531	111-44-0008
09348215058524	111-44-0207
09348215058517	111-44-0107
09348215058500	111-44-0007
09348215058494	111-44-0206
09348215058487	111-44-0106

Trademark Results [Spartan Hip Stem]

Mark Image Registration \| Serial	Company Trademark Application Date
SPARTAN HIP STEM 88805892 not registered Live/Pending	Signature Orthopaedics Pty Ltd 2020-02-21