E3D-A Interbody System 111-A36260811

GUDID 00195860018859

ALIF TRIAL 36 X 26mm 8deg 11mm (P 7 mm)

Evolution Spine LLC

Spinal implant trial
Primary Device ID00195860018859
NIH Device Record Key8544c972-2929-457b-83aa-c3eb88f75152
Commercial Distribution StatusIn Commercial Distribution
Brand NameE3D-A Interbody System
Version Model Number111-A36260811
Catalog Number111-A36260811
Company DUNS116940934
Company NameEvolution Spine LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100195860018859 [Primary]

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00195860018859]

Moist Heat or Steam Sterilization

[00195860018859]

Moist Heat or Steam Sterilization

[00195860018859]

Moist Heat or Steam Sterilization

[00195860018859]

Moist Heat or Steam Sterilization

[00195860018859]

Moist Heat or Steam Sterilization

[00195860018859]

Moist Heat or Steam Sterilization

[00195860018859]

Moist Heat or Steam Sterilization

[00195860018859]

Moist Heat or Steam Sterilization

[00195860018859]

Moist Heat or Steam Sterilization

[00195860018859]

Moist Heat or Steam Sterilization

[00195860018859]

Moist Heat or Steam Sterilization

[00195860018859]

Moist Heat or Steam Sterilization

[00195860018859]

Moist Heat or Steam Sterilization

[00195860018859]

Moist Heat or Steam Sterilization

[00195860018859]

Moist Heat or Steam Sterilization

[00195860018859]

Moist Heat or Steam Sterilization

[00195860018859]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-23
Device Publish Date2023-03-15

On-Brand Devices [E3D-A Interbody System]

10195860022761INTEGRATED ALIF 40 X 28mm 30deg 21mm (P 6mm)
10195860022754INTEGRATED ALIF 40 X 28mm 25deg 21mm (P 8mm)
10195860022747INTEGRATED ALIF 40 X 28mm 20deg 21mm (P 11mm)
10195860022730INTEGRATED ALIF 40 X 28mm 15deg 21mm (P 13mm)
10195860022723INTEGRATED ALIF 40 X 28mm 8deg 21mm (P 16mm)
10195860022716INTEGRATED ALIF 38 X 28mm 30deg 21mm (P 6mm)
10195860022709INTEGRATED ALIF 38 X 28mm 25deg 21mm (P 8mm)
10195860022693INTEGRATED ALIF 38 X 28mm 20deg 21mm (P 11mm)
10195860022686INTEGRATED ALIF 38 X 28mm 15deg 21mm (P 13mm)
10195860022679INTEGRATED ALIF 38 X 28mm 8deg 21mm (P 16mm)
10195860022662INTEGRATED ALIF 36 X 26mm 30deg 21mm (P 7mm)
10195860022655INTEGRATED ALIF 36 X 26mm 25deg 21mm (P 9mm)
10195860022648INTEGRATED ALIF 36 X 26mm 20deg 21mm (P 12mm)
10195860022631INTEGRATED ALIF 36 X 26mm 15deg 21mm (P 14mm)
10195860022624INTEGRATED ALIF 36 X 26mm 8deg 21mm (P 17mm)
10195860022617INTEGRATED ALIF 32 X 24mm 30deg 21mm (P 8mm)
10195860022600INTEGRATED ALIF 32 X 24mm 25deg 21mm (P 10mm)
10195860022594INTEGRATED ALIF 32 X 24mm 20deg 21mm (P 13mm)
10195860022587INTEGRATED ALIF 32 X 24mm 15deg 21mm (P 15mm)
10195860022570INTEGRATED ALIF 32 X 24mm 8deg 21mm (P 18mm)
10195860022563STATIC ALIF 40x28mm 30deg 21mm (P 6mm)
10195860022556STATIC ALIF 40x28mm 25deg 21mm (P 8mm)
10195860022549STATIC ALIF 40x28mm 20deg 21mm (P 11mm)
10195860022532STATIC ALIF 40x28mm 15deg 21mm (P 13mm)
10195860022525STATIC ALIF 40x28mm 8deg 21mm (P 16mm)
10195860022518STATIC ALIF 38x28mm 30deg 21mm (P 6mm)
10195860022501STATIC ALIF 38x28mm 25deg 21mm (P 8mm)
10195860022495STATIC ALIF 38x28mm 20deg 21mm (P 11mm)
10195860022488STATIC ALIF 38x28mm 15deg 21mm (P 13mm)
10195860022471STATIC ALIF 38x28mm 8deg 21mm (P 16mm)
10195860022464STATIC ALIF 36x26mm 30deg 21mm (P 7mm)
10195860022457STATIC ALIF 36x26mm 25deg 21mm (P 9mm)
10195860022440STATIC ALIF 36x26mm 20deg 21mm (P 12mm)
10195860022433STATIC ALIF 36x26mm 15deg 21mm (P 14mm)
10195860022426STATIC ALIF 36x26mm 8deg 21mm (P 17mm)
10195860022419STATIC ALIF 32x24mm 30deg 21mm (P 8mm)
10195860022402STATIC ALIF 32x24mm 25deg 21mm (P 10mm)
10195860022396STATIC ALIF 32x24mm 20deg 21mm (P 13mm)
10195860022389STATIC ALIF 32x24mm 15deg 21mm (P 15mm)
10195860022372STATIC ALIF 32x24mm 8deg 21mm (P 18mm)
10195860022259STATIC ALIF 40 X 28mm 30deg 20mm (P 5mm)
10195860022242STATIC ALIF 40 X 28mm 30deg 19mm (P 4mm)
10195860022235STATIC ALIF 40 X 28mm 30deg 18mm (P 3mm)
10195860022228STATIC ALIF 40 X 28mm 30deg 17mm (P 2mm)
10195860022211STATIC ALIF 40 X 28mm 25deg 20mm (P 7mm)
10195860022204STATIC ALIF 40 X 28mm 25deg 19mm (P 6mm)
10195860022198STATIC ALIF 40 X 28mm 25deg 18mm (P 5mm)
10195860022181STATIC ALIF 40 X 28mm 25deg 17mm (P 4mm)
10195860022174STATIC ALIF 40 X 28mm 25deg 16mm (P 3mm)
10195860022167STATIC ALIF 40 X 28mm 25deg 15mm (P 2mm)
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