Spartan Stem

GUDID 09348215093846

SIGNATURE ORTHOPAEDICS PTY LTD

Coated hip femur prosthesis, modular

• Primary Device ID: 09348215093846
• NIH Device Record Key: 7470b2a1-7a3c-495d-89da-e4cf2eaad029
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spartan Stem
• Version Model Number: 01-050-01-0006
• 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	09348215093846 [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