E3D®-C Interbody System 130-A043

GUDID 00195860025789

TRIAL 14 ' 12mm 12DEG 9mm-10mm

Evolution Spine LLC

Spinal implant trial
Primary Device ID00195860025789
NIH Device Record Keydd2f336b-cb2e-484a-aa5e-d564dc4ca89c
Commercial Distribution StatusIn Commercial Distribution
Brand NameE3D®-C Interbody System
Version Model Number130-A043
Catalog Number130-A043
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
GS100195860025789 [Primary]

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00195860025789]

Moist Heat or Steam Sterilization

[00195860025789]

Moist Heat or Steam Sterilization

[00195860025789]

Moist Heat or Steam Sterilization

[00195860025789]

Moist Heat or Steam Sterilization

[00195860025789]

Moist Heat or Steam Sterilization

[00195860025789]

Moist Heat or Steam Sterilization

[00195860025789]

Moist Heat or Steam Sterilization

[00195860025789]

Moist Heat or Steam Sterilization

[00195860025789]

Moist Heat or Steam Sterilization

[00195860025789]

Moist Heat or Steam Sterilization

[00195860025789]

Moist Heat or Steam Sterilization

[00195860025789]

Moist Heat or Steam Sterilization

[00195860025789]

Moist Heat or Steam Sterilization

[00195860025789]

Moist Heat or Steam Sterilization

[00195860025789]

Moist Heat or Steam Sterilization

[00195860025789]

Moist Heat or Steam Sterilization

[00195860025789]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-14
Device Publish Date2024-10-04

On-Brand Devices [E3D®-C Interbody System]

20195860025370HAnano E3D-C Anchor 18mm PACK OF 2
20195860025363HAnano E3D-C Anchor 16mm PACK OF 2
20195860025356HAnano E3D-C Anchor 14mm PACK OF 2
20195860025349HAnano E3D-C Anchor 12mm PACK OF 2
20195860025332HAnano E3D-C Anchor 10mm PACK OF 2
20195860025325HAnano E3D-C Screw 4.0 ' 26 PACK OF 2
20195860025318HAnano E3D-C Screw 4.0 ' 24 PACK OF 2
20195860025301HAnano E3D-C Screw 4.0 ' 22 PACK OF 2
20195860025295HAnano E3D-C Screw 4.0 ' 20 PACK OF 2
20195860025288HAnano E3D-C Screw 4.0 ' 18 PACK OF 2
20195860025271HAnano E3D-C Screw 4.0 ' 16 PACK OF 2
20195860025264HAnano E3D-C Screw 4.0 ' 14 PACK OF 2
20195860025257HAnano E3D-C Screw 4.0 ' 12 PACK OF 2
20195860025240HAnano E3D-C Screw 4.0 ' 10 PACK OF 2
20195860025233HAnano E3D-C Screw 3.5 ' 26 PACK OF 2
20195860025226HAnano E3D-C Screw 3.5 ' 24 PACK OF 2
20195860025219HAnano E3D-C Screw 3.5 ' 22 PACK OF 2
20195860025202HAnano E3D-C Screw 3.5 ' 20 PACK OF 2
20195860025196HAnano E3D-C Screw 3.5 ' 18 PACK OF 2
20195860025189HAnano E3D-C Screw 3.5 ' 16 PACK OF 2
20195860025172HAnano E3D-C Screw 3.5 ' 14 PACK OF 2
20195860025165HAnano E3D-C Screw 3.5 ' 12 PACK OF 2
20195860025158HAnano E3D-C Screw 3.5 ' 10 PACK OF 2
20195860024878HAnano Static Cervical 18'16mm 15Deg 12mm
20195860024861HAnano Static Cervical 18'16mm 15Deg 11mm
20195860024854HAnano Static Cervical 18'16mm 15Deg 10mm
20195860024847HAnano Static Cervical 18'16mm 15Deg 9mm
20195860024830HAnano Static Cervical 18'16mm 15Deg 8mm
20195860024823HAnano Static Cervical 18'16mm 15Deg 7mm
20195860024816HAnano Static Cervical 18'16mm 15Deg 6mm
20195860024809HAnano Static Cervical 18'16mm 12Deg 12mm
20195860024793HAnano Static Cervical 18'16mm 12Deg 11mm
20195860024786HAnano Static Cervical 18'16mm 12Deg 10mm
20195860024779HAnano Static Cervical 18'16mm 12Deg 9mm
20195860024762HAnano Static Cervical 18'16mm 12Deg 8mm
20195860024755HAnano Static Cervical 18'16mm 12Deg 7mm
20195860024748HAnano Static Cervical 18'16mm 12Deg 6mm
20195860024731HAnano Static Cervical 18'16mm 7Deg 12mm
20195860024724HAnano Static Cervical 18'16mm 7Deg 11mm
20195860024717HAnano Static Cervical 18'16mm 7Deg 10mm
20195860024700HAnano Static Cervical 18'16mm 7Deg 9mm
20195860024694HAnano Static Cervical 18'16mm 7Deg 8mm
20195860024687HAnano Static Cervical 18'16mm 7Deg 7mm
20195860024670HAnano Static Cervical 18'16mm 7Deg 6mm
20195860024663HAnano Static Cervical 18'16mm 7Deg 5mm
20195860024656HAnano Static Cervical 16'14mm 15Deg 12mm
20195860024649HAnano Static Cervical 16'14mm 15Deg 11mm
20195860024632HAnano Static Cervical 16'14mm 15Deg 10mm
20195860024625HAnano Static Cervical 16'14mm 15Deg 9mm
20195860024618HAnano Static Cervical 16'14mm 15Deg 8mm
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