| Primary Device ID | 00817701028475 |
| NIH Device Record Key | ee3dd030-b41c-4c63-94d9-323bae03dc03 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nextra PEEK Hammertoe Correction System |
| Version Model Number | PH42PKT |
| 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 | 00817701028475 [Primary] |
| HWC | Screw, Fixation, Bone |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-12-02 |
| Device Publish Date | 2021-11-24 |
| 00817701029212 | PEEK Hammertoe Sterile Angled Driver |
| 00817701029205 | PEEK Hammertoe Sterile Driver |
| 00817701028475 | PEEK Hammertoe Proximal 4.2mm Instrument Kit w/ Implant |
| 00817701028468 | PEEK Hammertoe Proximal 3.2mm Instrument Kit w/ Implant |
| 00817701028451 | PEEK Hammertoe Angled Middle 5.0mm |
| 00817701028444 | PEEK Hammertoe Angled Middle 4.25mm |
| 00817701028437 | PEEK Hammertoe Angled Middle 3.5mm |
| 00817701028420 | PEEK Hammertoe Middle 5.0 |
| 00817701028413 | PEEK Hammertoe Middle 4.25mm |
| 00817701028406 | PEEK Hammertoe Middle 3.5mm |
| 00817701028390 | PEEK Hammertoe Proximal 4.2mm |
| 00817701028383 | PEEK Hammertoe Proximal 3.2mm |