| 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 |
| 00195860029930 - E3D®-C Interbody System | 2025-09-16 SHORT FIXED ANGLE OUTER HOUSING |
| 00195860029947 - E3D®-C Interbody System | 2025-09-16 SHORT FIXED ANGLE DRILL TIP 12MM |
| 00195860029954 - E3D®-C Interbody System | 2025-09-16 E3D-C TRIAL TRAY TOP LEVEL INSERT |
| 00195860029961 - E3D®-C Interbody System | 2025-09-16 E3D-C INTEGRATED INSTRUMENTS MIDDLE LEVEL INSERT |
| 00195860029978 - E3D®-C Interbody System | 2025-09-16 E3D-C INTEGRATED INSTRUMENTS AND IMPLANTS BOTTOM LEVEL TRAY |
| 00195860029985 - E3D®-C Interbody System | 2025-09-16 E3D-C INSTRUMENTS TRAY LID |
| 00195860029992 - E3D®-C Interbody System | 2025-09-16 E3D-C DRILL AND DRIVER CADDY |
| 00195860030004 - E3D®-C Interbody System | 2025-09-16 E3D-C STATIC INSTRUMENTS BOTTOM LEVEL TRAY |