Cervical Interbody Fusion System CSP1012

GUDID 00195860005620

Cervical IBD, 12x14x12mm, 10 Deg

Evolution Spine LLC

Polymeric spinal interbody fusion cage
Primary Device ID00195860005620
NIH Device Record Key9d84ce19-8773-453f-815c-a6ad1411cc16
Commercial Distribution StatusIn Commercial Distribution
Brand NameCervical Interbody Fusion System
Version Model NumberCSP1012
Catalog NumberCSP1012
Company DUNS116940934
Company NameEvolution Spine LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Device Dimensions

Angle10 degree
Width12 Millimeter
Depth14 Millimeter
Height12 Millimeter
Angle10 degree
Width12 Millimeter
Depth14 Millimeter
Height12 Millimeter
Angle10 degree
Width12 Millimeter
Depth14 Millimeter
Height12 Millimeter
Angle10 degree
Width12 Millimeter
Depth14 Millimeter
Height12 Millimeter
Angle10 degree
Width12 Millimeter
Depth14 Millimeter
Height12 Millimeter
Angle10 degree
Width12 Millimeter
Depth14 Millimeter
Height12 Millimeter
Angle10 degree
Width12 Millimeter
Depth14 Millimeter
Height12 Millimeter
Angle10 degree
Width12 Millimeter
Depth14 Millimeter
Height12 Millimeter
Angle10 degree
Width12 Millimeter
Depth14 Millimeter
Height12 Millimeter
Angle10 degree
Width12 Millimeter
Depth14 Millimeter
Height12 Millimeter
Angle10 degree
Width12 Millimeter
Depth14 Millimeter
Height12 Millimeter
Angle10 degree
Width12 Millimeter
Depth14 Millimeter
Height12 Millimeter
Angle10 degree
Width12 Millimeter
Depth14 Millimeter
Height12 Millimeter
Angle10 degree
Width12 Millimeter
Depth14 Millimeter
Height12 Millimeter
Angle10 degree
Width12 Millimeter
Depth14 Millimeter
Height12 Millimeter
Angle10 degree
Width12 Millimeter
Depth14 Millimeter
Height12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100195860005620 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral fusion device with bone graft, cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00195860005620]

Moist Heat or Steam Sterilization

[00195860005620]

Moist Heat or Steam Sterilization

[00195860005620]

Moist Heat or Steam Sterilization

[00195860005620]

Moist Heat or Steam Sterilization

[00195860005620]

Moist Heat or Steam Sterilization

[00195860005620]

Moist Heat or Steam Sterilization

[00195860005620]

Moist Heat or Steam Sterilization

[00195860005620]

Moist Heat or Steam Sterilization

[00195860005620]

Moist Heat or Steam Sterilization

[00195860005620]

Moist Heat or Steam Sterilization

[00195860005620]

Moist Heat or Steam Sterilization

[00195860005620]

Moist Heat or Steam Sterilization

[00195860005620]

Moist Heat or Steam Sterilization

[00195860005620]

Moist Heat or Steam Sterilization

[00195860005620]

Moist Heat or Steam Sterilization

[00195860005620]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-02
Device Publish Date2021-05-25

On-Brand Devices [Cervical Interbody Fusion System]

0019586001270314x16x 10mm, 11mm , 10 Deg Trial - No Stop
0019586001269714x16x 8mm, 9mm , 10 Deg Trial - No Stop
0019586001268014x16x 6mm, 7mm, 10 Deg Trial - No Stop
0019586001267314x16x 10mm, 11mm , 6 Deg Trial - No Stop
0019586001266614x16x 8mm, 9mm , 6 Deg Trial - No Stop
0019586001265914x16x 6mm, 7mm, 6 Deg Trial - No Stop
0019586001264214x16x 5mm, 6 Deg Trial - No Stop
0019586001263512x14x 10mm, 11mm , 10 Deg Trial - No Stop
0019586001262812x14x 8mm, 9mm , 10 Deg Trial - No Stop
0019586001261112x14x 6mm, 7mm, 10 Deg Trial - No Stop
0019586001260412x14x 10mm, 11mm , 6 Deg Trial - No Stop
0019586001259812x14x 8mm, 9mm , 6 Deg Trial - No Stop
0019586001258112x14x 6mm, 7mm, 6 Deg Trial - No Stop
0019586001257412x14x 5mm, 6 Deg Trial - No Stop
00195860006139ACDF Implants Caddy Lid
00195860006122ACDF Large Implants Caddy
00195860006115ACDF Small Implants Caddy
00195860006108ACDF Large Implants / Instruments Tray
00195860006092ACDF Small Implants / Instruments Tray
00195860006085ACDF Tray Lid
0019586000607814x16x 10mm, 11mm , 10 Deg Trial
0019586000606114x16x 8mm, 9mm , 10 Deg Trial
0019586000605414x16x 6mm, 7mm, 10 Deg Trial
0019586000604714x16x 10mm, 11mm , 6 Deg Trial
0019586000603014x16x 8mm, 9mm , 6 Deg Trial
0019586000602314x16x 6mm, 7mm, 6 Deg Trial
0019586000601614x16x 5mm, 6 Deg, 10 Deg Trial
0019586000600912x14x 10mm, 11mm , 10 Deg Trial
0019586000599612x14x 8mm, 9mm , 10 Deg Trial
0019586000598912x14x 6mm, 7mm, 10 Deg Trial
0019586000597212x14x 10mm, 11mm , 6 Deg Trial
0019586000596512x14x 8mm, 9mm , 6 Deg Trial
0019586000595812x14x 6mm, 7mm, 6 Deg Trial
0019586000594112x14x5mm, 6 Deg, 10 Deg Trial
0019586000593414x16x 10mm, 11mm Rasp
0019586000592714x16x 8mm, 9mm Rasp
0019586000591014x16x 6mm, 7mm Rasp
0019586000590314x16x5mm Rasp
0019586000589712x14x 10mm, 11mm Rasp
0019586000588012x14x 8mm, 9mm Rasp
0019586000587312x14x 6mm, 7mm Rasp
0019586000586612x14x5mm Rasp
00195860005859Cervical Tamp
00195860005842Cervical Inserter
00195860005835Cervical IBD, 14x16x14mm, 10 Deg
00195860005828Cervical IBD, 14x16x13mm, 10 Deg
00195860005811Cervical IBD, 14x16x12mm, 10 Deg
00195860005804Cervical IBD, 14x16x11mm, 10 Deg
00195860005798Cervical IBD, 14x16x10mm, 10 Deg
00195860005781Cervical IBD, 14x16x9mm, 10 Deg
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.