| Primary Device ID | 00846468034290 |
| NIH Device Record Key | 8fd08291-22a8-4187-93db-28f49354daf9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cross-Fuse PEEK IBF System |
| Version Model Number | 35-1450-11 |
| Catalog Number | 35-1450-11 |
| Company DUNS | 793384496 |
| Company Name | Pioneer Surgical Technology, 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 | false |
| 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 |
| 00846468092641 | VBR, Crossfuse, 13x18x55x6 spacer |
| 00846468041090 | TRIAL CADDY |
| 00846468041083 | TAMP |
| 00846468041069 | INSERTER, MODULAR CLEANING |
| 00846468040987 | INSERTER, MODULAR CLEANING |
| 00846468040963 | TRIAL SPACER |
| 00846468039318 | TRIAL SPACER |
| 00846468039301 | TRIAL SPACER |
| 00846468039288 | TRIAL SPACER |
| 00846468039134 | TRIAL SPACER |
| 00846468039066 | TRIAL SPACER |
| 00846468039059 | TRIAL SPACER |
| 00846468039042 | TRIAL SPACER |
| 00846468039028 | TRIAL SPACER |
| 00846468039011 | TRIAL SPACER |
| 00846468035945 | TRIAL SPACER |
| 00846468035938 | TRIAL SPACER |
| 00846468035914 | TRIAL SPACER |
| 00846468035891 | 22X55X9MM 6 DEGREE CROSSFUSE IMPLANTS |
| 00846468035884 | 22X55X9MM CROSSFUSE IMPLANTS |
| 00846468035846 | 22X55X13MM CROSSFUSE IMPLANTS |
| 00846468035822 | 22X55X11MM CROSSFUSE IMPLANTS |
| 00846468035815 | 22X50X9MM 6 DEGREE CROSSFUSE IMPLANTS |
| 00846468035778 | 22X50X13MM 6 DEGREE CROSSFUSE IMPLANTS |
| 00846468035761 | 22X50X13MM CROSSFUSE IMPLANTS |
| 00846468035723 | 22X45X9MM CROSSFUSE IMPLANTS |
| 00846468035716 | 22X45X15MM 6DEGREE CROSSFUSE IMPLANTS |
| 00846468035693 | 22X45X13MM 6DEGREE CROSSFUSE IMPLANTS |
| 00846468035679 | 22X45X11MM 6DEGREE CROSSFUSE IMPLANTS |
| 00846468035662 | 22X45X11MM CROSSFUSE IMPLANTS |
| 00846468035631 | Crossfuse, 17x18x60x6 spacer |
| 00846468035617 | Crossfuse, 15x18x60x6 spacer |
| 00846468035594 | Crossfuse, 13x18x60x6 spacer |
| 00846468035587 | Crossfuse, 13x18x60x0 spacer |
| 00846468035549 | VBR, Crossfuse, 9x18x55x0 spacer |
| 00846468035525 | VBR, Crossfuse, 17x18x55x0 spacer |
| 00846468035518 | VBR, Crossfuse, 15x18x55x6 spacer |
| 00846468035464 | VBR, Crossfuse, 11x18x55x0 spacer |
| 00846468035440 | VBR, Crossfuse, 9x18x50x0 spacer |
| 00846468035433 | VBR, Crossfuse, 17x18x50x6 spacer |
| 00846468035402 | VBR, Crossfuse, 15x18x50x0 spacer |
| 00846468035365 | VBR, Crossfuse, 13x18x50x0 spacer |
| 00846468035341 | VBR, Crossfuse, 11x18x50x6 spacer |
| 00846468035273 | VBR, Crossfuse, 11x18x50x0 spacer |
| 00846468035235 | VBR, Crossfuse, 9x18x45x0 spacer |
| 00846468035228 | VBR, Crossfuse, 15x18x45x6 spacer |
| 00846468035174 | VBR, Crossfuse, 13x18x45x6 spacer |
| 00846468035129 | 35-1845-11-6se, 11x18x45x0 spacer |
| 00846468035112 | VBR, Crossfuse, 9x18x40x0 spacer |
| 00846468035082 | VBR, Crossfuse, 13x18x40x0 spacer |