| Primary Device ID | 00817701029014 |
| NIH Device Record Key | df319df6-8ee5-48f4-911c-cd7efdbb499d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | InCore Subtalar |
| Version Model Number | ICSUB55084 |
| Company DUNS | 192756786 |
| Company Name | Medartis Inc. |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817701029014 [Primary] |
| HWC | Screw, Fixation, Bone |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-09-29 |
| Device Publish Date | 2023-01-31 |
| 00817701029250 | InCore Subtalar Implant Bushing, Large |
| 00817701029243 | InCore Subtalar Implant Bushing, Medium |
| 00817701029236 | InCore Subtalar Implant Bushing, Small |
| 00817701029229 | InCore Subtalar Drill Bushing, Large |
| 00817701028833 | InCore Subtalar Replacement Compression Screw |
| 00817701028826 | InCore Subtalar Replacement Compression Frame Left |
| 00817701028819 | InCore Subtalar Replacement Compression Frame Right |
| 00817701028802 | InCore Subtalar 5.6mm Drill Bit Disposable |
| 00817701028796 | InCore Subtalar T25 Driver Disposable |
| 00817701028789 | InCore Subtalar 8.0mm Post Drill Disposable |
| 00817701028772 | InCore Subtalar Instrument Case Lid |
| 00817701028765 | InCore Subtalar Instrument Case |
| 00817701028741 | InCore Subtalar Depth Probe |
| 00817701028734 | InCore Subtalar Removal Fastener |
| 00817701028727 | InCore Subtalar Removal Slap Hammer |
| 00817701028710 | InCore Subtalar Removal Drill Guide |
| 00817701028703 | InCore Subtalar 5.6mm Drill Bit |
| 00817701028697 | InCore Subtalar T25 Driver |
| 00817701028680 | InCore Subtalar 8.0mm Post Drill |
| 00817701028673 | InCore Subtalar Post Fastener |
| 00817701028666 | InCore Subtalar Drill Bushing, Medium |
| 00817701028659 | InCore Subtalar Drill Bushing, Small |
| 00817701028642 | InCore Subtalar Targeting Guide Assembly Left |
| 00817701028635 | InCore Subtalar Targeting Guide Assembly Right |
| 00817701028628 | InCore Subtalar Post Guide Left |
| 00817701028611 | InCore Subtalar Post Guide Right |
| 00817701029298 | InCore Subtalar K-Wires, Sterile |
| 00817701029144 | InCore Subtalar 5.5mm x 110mm Screw |
| 00817701029137 | InCore Subtalar 5.5mm x 108mm Screw |
| 00817701029120 | InCore Subtalar 5.5mm x 106mm Screw |
| 00817701029113 | InCore Subtalar 5.5mm x 104mm Screw |
| 00817701029106 | InCore Subtalar 5.5mm x 102mm Screw |
| 00817701029090 | InCore Subtalar 5.5mm x 100mm Screw |
| 00817701029083 | InCore Subtalar 5.5mm x 98mm Screw |
| 00817701029076 | InCore Subtalar 5.5mm x 96mm Screw |
| 00817701029069 | InCore Subtalar 5.5mm x 94mm Screw |
| 00817701029052 | InCore Subtalar 5.5mm x 92mm Screw |
| 00817701029045 | InCore Subtalar 5.5mm x 90mm Screw |
| 00817701029038 | InCore Subtalar 5.5mm x 88mm Screw |
| 00817701029021 | InCore Subtalar 5.5mm x 86mm Screw |
| 00817701029014 | InCore Subtalar 5.5mm x 84mm Screw |
| 00817701029007 | InCore Subtalar 5.5mm x 82mm Screw |
| 00817701028994 | InCore Subtalar 5.5mm x 80mm Screw |
| 00817701028987 | InCore Subtalar 5.5mm x 78mm Screw |
| 00817701028970 | InCore Subtalar 5.5mm x 76mm Screw |
| 00817701028963 | InCore Subtalar 5.5mm x 74mm Screw |
| 00817701028956 | InCore Subtalar 5.5mm x 72mm Screw |
| 00817701028949 | InCore Subtalar 5.5mm x 70mm Screw |
| 00817701028932 | InCore Subtalar 5.5mm x 68mm Screw |
| 00817701028925 | InCore Subtalar 5.5mm x 66mm Screw |