Spartan Hip Stem
GUDID 09348215058975
SIGNATURE ORTHOPAEDICS PTY LTD
Coated hip femur prosthesis, modular| Primary Device ID | 09348215058975 |
| NIH Device Record Key | 6ac1de74-a410-45db-8d03-0f554b84e039 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spartan Hip Stem |
| Version Model Number | 111-44-1210 |
| 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 | 09348215058975 [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]
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 |
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