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 |