Signature Femoral Head

GUDID 09348215001919

SIGNATURE ORTHOPAEDICS PTY LTD

Ceramic femoral head prosthesis

• Primary Device ID: 09348215001919
• NIH Device Record Key: dd1c6c36-1e70-470f-b460-a0e215809a41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Signature Femoral Head
• Version Model Number: 111-152-613
• 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	09348215001919 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121297

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-09
• Device Publish Date: 2015-09-28

On-Brand Devices [Signature Femoral Head]

• 09348215017903: 111-152-003
• 09348215017897: 111-152-002
• 09348215017880: 111-152-001
• 09348215001797: 111-152-044
• 09348215001780: 111-152-043
• 09348215001773: 111-152-042
• 09348215001766: 111-152-041
• 09348215001759: 111-152-034
• 09348215001742: 111-152-033
• 09348215001735: 111-152-032
• 09348215001728: 111-152-031
• 09348215001711: 111-152-024
• 09348215001704: 111-152-023
• 09348215001698: 111-152-022
• 09348215001681: 111-152-021
• 09348215001674: 111-152-013
• 09348215001667: 111-152-012
• 09348215001650: 111-152-011
• 09348215002039: 111-152-644
• 09348215002022: 111-152-643
• 09348215002015: 111-152-642
• 09348215002008: 111-152-641
• 09348215001995: 111-152-634
• 09348215001988: 111-152-633
• 09348215001971: 111-152-632
• 09348215001964: 111-152-631
• 09348215001957: 111-152-624
• 09348215001940: 111-152-623
• 09348215001933: 111-152-622
• 09348215001926: 111-152-621
• 09348215001919: 111-152-613
• 09348215001902: 111-152-612
• 09348215001896: 111-152-611
• 09348215001889: 111-152-533
• 09348215001872: 111-152-532
• 09348215001865: 111-152-531
• 09348215001858: 111-152-523
• 09348215001841: 111-152-522
• 09348215001834: 111-152-521
• 09348215001827: 111-152-513
• 09348215001810: 111-152-512
• 09348215001803: 111-152-511
• 09348215095611: 01-045-00-4008
• 09348215095604: 01-045-00-4004
• 09348215095598: 01-045-00-4000
• 09348215095581: 01-045-00-4094
• 09348215095574: 01-045-00-3608
• 09348215095567: 01-045-00-3604
• 09348215095550: 01-045-00-3600
• 09348215095543: 01-045-00-3694