Spartan Stem

GUDID 09348215093853

SIGNATURE ORTHOPAEDICS PTY LTD

Coated hip femur prosthesis, modular
Primary Device ID09348215093853
NIH Device Record Key66ab9956-4e3a-42ec-8da8-ac9e1940559c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpartan Stem
Version Model Number01-050-01-0007
Company DUNS751993028
Company NameSIGNATURE ORTHOPAEDICS PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109348215093853 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-18
Device Publish Date2022-03-10

On-Brand Devices [Spartan Stem]

0934821509401001-050-01-0112
0934821509400301-050-01-0111
0934821509399001-050-01-0110
0934821509398301-050-01-0109
0934821509397601-050-01-0108
0934821509396901-050-01-0107
0934821509395201-050-01-0106
0934821509394501-050-01-0105
0934821509393801-050-01-0104
0934821509392101-050-01-0103
0934821509391401-050-01-0102
0934821509390701-050-01-0012
0934821509389101-050-01-0011
0934821509388401-050-01-0010
0934821509387701-050-01-0009
0934821509386001-050-01-0008
0934821509385301-050-01-0007
0934821509384601-050-01-0006
0934821509383901-050-01-0005
0934821509382201-050-01-0004
0934821509381501-050-01-0003
0934821509380801-050-01-0002
0934821509379201-050-01-0212
0934821509378501-050-01-0211
0934821509377801-050-01-0210
0934821509376101-050-01-0209
0934821509375401-050-01-0208
0934821509374701-050-01-0207
0934821509373001-050-01-0206
0934821509372301-050-01-0205
0934821509371601-050-01-0204
0934821509370901-050-01-0203
0934821509369301-050-01-0202

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