Encore Hip Stem

GUDID 09348215082994

SIGNATURE ORTHOPAEDICS PTY LTD

Coated hip femur prosthesis, modular

• Primary Device ID: 09348215082994
• NIH Device Record Key: b0175149-cad7-403a-bfbd-66525cf526c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Encore Hip Stem
• Version Model Number: 111-45-0613
• 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	09348215082994 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211505

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: 2021-10-13
• Device Publish Date: 2021-10-05

On-Brand Devices [Encore Hip Stem]

• 09348215083052: 111-45-1213
• 09348215083045: 111-45-1113
• 09348215083038: 111-45-1013
• 09348215083021: 111-45-0913
• 09348215083014: 111-45-0813
• 09348215083007: 111-45-0713
• 09348215082994: 111-45-0613
• 09348215082987: 111-45-1212
• 09348215082970: 111-45-1112
• 09348215082963: 111-45-1012
• 09348215082956: 111-45-0912
• 09348215082949: 111-45-0812
• 09348215082932: 111-45-0712
• 09348215082925: 111-45-0612
• 09348215082918: 111-45-0512
• 09348215082901: 111-45-0412
• 09348215082895: 111-45-0312
• 09348215082888: 111-45-0212
• 09348215082871: 111-45-0112
• 09348215082864: 111-45-0012
• 09348215082857: 111-45-1211
• 09348215082840: 111-45-1111
• 09348215082833: 111-45-1011
• 09348215082826: 111-45-0911
• 09348215082819: 111-45-0811
• 09348215082802: 111-45-0711
• 09348215082796: 111-45-0611
• 09348215082789: 111-45-0511
• 09348215082772: 111-45-0411
• 09348215082765: 111-45-0311
• 09348215082758: 111-45-0211
• 09348215082741: 111-45-0111
• 09348215082734: 111-45-0011