| Primary Device ID | 00817701021124 |
| NIH Device Record Key | d327d979-268f-45a3-be79-15781b068e85 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | InCore Lapidus |
| Version Model Number | IC-LAP-3546 |
| Company DUNS | 060783407 |
| Company Name | NEXTREMITY SOLUTIONS, 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817701021124 [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 | 2020-05-04 |
| Device Publish Date | 2018-08-23 |
| 00817701021384 | InCore Lapidus Torque Limiting Handle |
| 00817701021353 | Lapidus Replacement Compression Screw Reusable |
| 00817701021346 | Lapidus Replacement Compression Frame Reusable |
| 00817701021322 | Instrument Case Lid Reusable |
| 00817701021315 | Instrument Case Reusable |
| 00817701021308 | Ratchet Handle Reusable |
| 00817701021292 | Depth Probe Reusable |
| 00817701021285 | Removal Fastener Reusable |
| 00817701021278 | Removal Slap Hammer Reusable |
| 00817701021261 | Removal Drill Guide Reusable |
| 00817701021254 | 3.6mm Drill Bit Reusable |
| 00817701021247 | T10 Driver Reusable |
| 00817701021230 | 5.9mm Post Drill Reusable |
| 00817701021223 | Post Fastener Reusable |
| 00817701021216 | Drill Bushing 70mm Reusable |
| 00817701021209 | Drill Bushing 55mm Reusable |
| 00817701021193 | Drill Bushing 40mm Reusable |
| 00817701021186 | 2mm X 4" K-Wire |
| 00817701021179 | Targeting Guide Assembly Right Reusable |
| 00817701021162 | Targeting Guide Assembly Left Reusable |
| 00817701021155 | Post Guide Right Reusable |
| 00817701021148 | Post Guide Left Reusable |
| 00817701021131 | InCore Lapidus Post Plug Screw |
| 00817701021124 | InCore Lapidus 3.5mm X 46mm Titanium Screw |
| 00817701021117 | InCore Lapidus 3.5mm X 60mm Titanium Screw |
| 00817701021100 | InCore Lapidus 3.5mm X 58mm Titanium Screw |
| 00817701021094 | InCore Lapidus 3.5mm X 56mm Titanium Screw |
| 00817701021087 | InCore Lapidus 3.5mm X 54mm Titanium Screw |
| 00817701021070 | InCore Lapidus 3.5mm X 52mm Titanium Screw |
| 00817701021063 | InCore Lapidus 3.5mm X 50mm Titanium Screw |
| 00817701021056 | InCore Lapidus 3.5mm X 48mm Titanium Screw |
| 00817701021049 | InCore Lapidus 3.5mm X 44mm Titanium Screw |
| 00817701021032 | InCore Lapidus 3.5mm X 42mm Titanium Screw |
| 00817701021025 | InCore Lapidus 3.5mm X 40mm Titanium Screw |
| 00817701021018 | InCore Lapidus 3.5mm X 38mm Titanium Screw |
| 00817701021001 | InCore Lapidus 3.5mm X 36mm Titanium Screw |
| 00817701020998 | InCore Lapidus 3.5mm X 34mm Titanium Screw |
| 00817701020981 | InCore Lapidus 3.5mm X 32mm Titanium Screw |
| 00817701020974 | InCore Lapidus 3.5mm X 30mm Titanium Screw |
| 00817701020967 | InCore Lapidus 3.5mm X 28mm Titanium Screw |
| 00817701020950 | InCore Lapidus 3.5mm X 26mm Titanium Screw |
| 00817701020943 | InCore Lapidus 3.5mm X 24mm Titanium Screw |
| 00817701020936 | InCore Lapidus 5.9mm X 32mm Left Titanium Post |
| 00817701020929 | InCore Lapidus 5.9mm X 32mm Right Titanium Post |
| 00817701020912 | InCore Lapidus 5.9mm X 28mm Left Titanium Post |
| 00817701020905 | InCore Lapidus 5.9mm X 28mm Right Titanium Post |
| 00817701020899 | InCore Lapidus 5.9mm X 32mm Left Kit |
| 00817701020882 | IC-LAP-32R |
| 00817701020875 | InCore Lapidus 5.9mm X 28mm Left Kit |
| 00817701020868 | InCore Lapidus 5.9mm X 28mm Right Kit |