Primary Device ID | 00195860023280 |
NIH Device Record Key | a64796e7-bd5b-49cc-8b36-6b813d607690 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | E3D-A Anchor System |
Version Model Number | 112-A013 |
Catalog Number | 112-A013 |
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)682-8536 |
info@evolutionspine.com | |
Phone | +1(214)682-8536 |
info@evolutionspine.com | |
Phone | +1(214)682-8536 |
info@evolutionspine.com | |
Phone | +1(214)682-8536 |
info@evolutionspine.com | |
Phone | +1(214)682-8536 |
info@evolutionspine.com | |
Phone | +1(214)682-8536 |
info@evolutionspine.com | |
Phone | +1(214)682-8536 |
info@evolutionspine.com | |
Phone | +1(214)682-8536 |
info@evolutionspine.com | |
Phone | +1(214)682-8536 |
info@evolutionspine.com | |
Phone | +1(214)682-8536 |
info@evolutionspine.com | |
Phone | +1(214)682-8536 |
info@evolutionspine.com | |
Phone | +1(214)682-8536 |
info@evolutionspine.com | |
Phone | +1(214)682-8536 |
info@evolutionspine.com | |
Phone | +1(214)682-8536 |
info@evolutionspine.com | |
Phone | +1(214)682-8536 |
info@evolutionspine.com | |
Phone | +1(214)682-8536 |
info@evolutionspine.com | |
Phone | +1(214)682-8536 |
info@evolutionspine.com | |
Phone | +1(214)682-8536 |
info@evolutionspine.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00195860023280 [Primary] |
PHM | Intervertebral fusion device with bone graft, thoracic |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00195860023280]
Moist Heat or Steam Sterilization
[00195860023280]
Moist Heat or Steam Sterilization
[00195860023280]
Moist Heat or Steam Sterilization
[00195860023280]
Moist Heat or Steam Sterilization
[00195860023280]
Moist Heat or Steam Sterilization
[00195860023280]
Moist Heat or Steam Sterilization
[00195860023280]
Moist Heat or Steam Sterilization
[00195860023280]
Moist Heat or Steam Sterilization
[00195860023280]
Moist Heat or Steam Sterilization
[00195860023280]
Moist Heat or Steam Sterilization
[00195860023280]
Moist Heat or Steam Sterilization
[00195860023280]
Moist Heat or Steam Sterilization
[00195860023280]
Moist Heat or Steam Sterilization
[00195860023280]
Moist Heat or Steam Sterilization
[00195860023280]
Moist Heat or Steam Sterilization
[00195860023280]
Moist Heat or Steam Sterilization
[00195860023280]
Moist Heat or Steam Sterilization
[00195860023280]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-06-03 |
Device Publish Date | 2024-05-24 |
40195860023202 | HAnano E3D-A Anchors 30mm PACK OF 3 |
40195860023189 | HAnano E3D-A Anchors 20mm PACK OF 3 |
30195860023205 | HAnano E3D-A Anchors 30mm PACK OF 2 |
30195860023182 | HAnano E3D-A Anchors 20mm PACK OF 2 |
20195860023208 | HAnano E3D-A Anchors 30mm |
00195860023471 | Freehand Anchor Tamp |
00195860023389 | ALIF Anchor Upper Tray |
00195860023334 | ALIF Anchor Caddy |
00195860023327 | ALIF Anchor Tray |
00195860023310 | E3D-A Anchor Inserter 19 mm |
00195860023303 | E3D-A Anchor Inserter 17 mm |
00195860023297 | E3D-A Anchor Inserter 15 mm |
00195860023280 | E3D-A Anchor Inserter 13 mm |
00195860023273 | E3D-A Anchor Inserter 12 mm |
00195860023266 | E3D-A Anchor Inserter 11 mm |
00195860023259 | Angled Anchor Extractor |
00195860023242 | Straight Anchor Extractor |
00195860023235 | Anchor Inserter Drawbar |
00195860023228 | Anchor Inserter Tamp |
00195860023211 | Anchor Mallet |
00195860023198 | E3D-A Anchor (Non-Sterile) 25mm |
20195860023192 | HAnano E3D-A Anchors 25mm |
20195860023185 | HAnano E3D-A Anchors 20mm |
10195860023201 | E3D-A Anchors 30mm |
10195860023195 | E3D-A Anchors 25mm |
10195860023188 | E3D-A Anchors 20mm |
00195860023204 | E3D-A Anchor (Non-Sterile) 30mm |
00195860023181 | E3D-A Anchor (Non-Sterile) 20mm |
40195860023196 | HAnano E3D-A Anchors 25mm PACK OF 3 |
30195860023199 | HAnano E3D-A Anchors 25mm PACK OF 2 |