| Primary Device ID | 00195860030028 |
| NIH Device Record Key | b075e922-e985-409a-a991-5e50c62c747f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Whistler Pedicle Screw System |
| Version Model Number | WI-079 |
| Catalog Number | WI-079 |
| Company DUNS | 116940934 |
| Company Name | Evolution Spine 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(214)281-8871 |
| info@evolutionspine.com | |
| Phone | +1(214)281-8871 |
| info@evolutionspine.com | |
| Phone | +1(214)281-8871 |
| info@evolutionspine.com | |
| Phone | +1(214)281-8871 |
| info@evolutionspine.com | |
| Phone | +1(214)281-8871 |
| info@evolutionspine.com | |
| Phone | +1(214)281-8871 |
| info@evolutionspine.com | |
| Phone | +1(214)281-8871 |
| info@evolutionspine.com | |
| Phone | +1(214)281-8871 |
| info@evolutionspine.com | |
| Phone | +1(214)281-8871 |
| info@evolutionspine.com | |
| Phone | +1(214)281-8871 |
| info@evolutionspine.com | |
| Phone | +1(214)281-8871 |
| info@evolutionspine.com | |
| Phone | +1(214)281-8871 |
| info@evolutionspine.com | |
| Phone | +1(214)281-8871 |
| info@evolutionspine.com | |
| Phone | +1(214)281-8871 |
| info@evolutionspine.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00195860030028 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-08 |
| Device Publish Date | 2025-08-29 |
| 00195860031728 - Emerge Cervical Plate | 2026-01-28 Emerge Cervical Instrument Tray V2 Top Level |
| 00195860031735 - Emerge Cervical Plate | 2026-01-28 Emerge Anterior Cervical Plate System Caddy V2 1 & 2 Level Plates |
| 00195860031742 - Emerge Cervical Plate | 2026-01-28 Emerge Anterior Cervical Plate System Caddy V2 3 Level Plates |
| 00195860031759 - Emerge Cervical Plate | 2026-01-28 Emerge Anterior Cervical Plate System Caddy V2 4 Level Plates |
| 00195860031766 - Emerge Cervical Plate | 2026-01-28 Emerge Anterior Cervical Plate System Caddy V2 5 Level Plates |
| 00195860031773 - Emerge Cervical Plate | 2026-01-28 Emerge Anterior Cervical Plate System Caddy V2 Variable Cervical Screws |
| 00195860031780 - Emerge Cervical Plate | 2026-01-28 Emerge Anterior Cervical Plate System Caddy V2 Fixed Cervical Screws |
| 00195860031797 - Emerge Cervical Plate | 2026-01-28 Emerge Cervical Implant Tray V2 Bottom Level |