| Primary Device ID | 00810028393523 |
| NIH Device Record Key | ed05bd16-602d-4c1f-99dc-1f568845ca34 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 11mm STAR E+ Sliding Core STAR Total Ankle |
| Version Model Number | 602-03-011 |
| Company DUNS | 828829072 |
| Company Name | Trilliant Surgical, LLC |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810028393523 [Primary] |
| NTG | Prosthesis, Ankle, Uncemented, Non-Constrained |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-14 |
| Device Publish Date | 2024-08-06 |
| 00190446898269 - Stabilization | 2024-12-26 Arsenal Ankle Drill Tower Modular Bracket |
| 00810028394414 - STAR Instrument Case Lid, Gen II STAR Ankle | 2024-11-11 |
| 00810028394438 - Instrument Case #3, Gen II STAR Ankle | 2024-11-11 |
| 00810028394445 - Right Talar Cut Guide Assy, Gen II STAR Ankle | 2024-11-11 |
| 00810028394452 - Talar Cut Guide Caddy Lid, Gen II STAR Ankle | 2024-11-11 |
| 00810028394469 - Left Talar Cut Guide Caddy Assy, Gen II STAR Ankle | 2024-11-11 |
| 00810028394476 - PE Trial Caddy Assy, Gen II | 2024-11-11 |
| 00810028394483 - PE Trial Caddy Lid, Gen II STAR Ankle | 2024-11-11 |