TrellOss™-C SA

GUDID 00840067205808

TrellOss-C SA 14Dx16Wx11H 6°

NEXXT SPINE, LLC

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage
Primary Device ID00840067205808
NIH Device Record Key698cbc41-c7e7-42b9-86ed-d8cedc7c85ee
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrellOss™-C SA
Version Model Number108N1411
Company DUNS003489810
Company NameNEXXT 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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com

Device Dimensions

Width16 Millimeter
Depth14 Millimeter
Height11 Millimeter
Angle6 degree
Width16 Millimeter
Depth14 Millimeter
Height11 Millimeter
Angle6 degree
Width16 Millimeter
Depth14 Millimeter
Height11 Millimeter
Angle6 degree
Width16 Millimeter
Depth14 Millimeter
Height11 Millimeter
Angle6 degree
Width16 Millimeter
Depth14 Millimeter
Height11 Millimeter
Angle6 degree
Width16 Millimeter
Depth14 Millimeter
Height11 Millimeter
Angle6 degree
Width16 Millimeter
Depth14 Millimeter
Height11 Millimeter
Angle6 degree
Width16 Millimeter
Depth14 Millimeter
Height11 Millimeter
Angle6 degree
Width16 Millimeter
Depth14 Millimeter
Height11 Millimeter
Angle6 degree
Width16 Millimeter
Depth14 Millimeter
Height11 Millimeter
Angle6 degree
Width16 Millimeter
Depth14 Millimeter
Height11 Millimeter
Angle6 degree
Width16 Millimeter
Depth14 Millimeter
Height11 Millimeter
Angle6 degree
Width16 Millimeter
Depth14 Millimeter
Height11 Millimeter
Angle6 degree
Width16 Millimeter
Depth14 Millimeter
Height11 Millimeter
Angle6 degree
Width16 Millimeter
Depth14 Millimeter
Height11 Millimeter
Angle6 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100840067205808 [Primary]
GS100840067205808 [Primary]
GS100840067205808 [Primary]
GS100840067205808 [Primary]
GS100840067205808 [Primary]
GS100840067205808 [Primary]
GS100840067205808 [Primary]
GS100840067205808 [Primary]
GS100840067205808 [Primary]
GS100840067205808 [Primary]
GS100840067205808 [Primary]
GS100840067205808 [Primary]
GS100840067205808 [Primary]
GS100840067205808 [Primary]
GS100840067205808 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-17
Device Publish Date2020-06-09

On-Brand Devices [TrellOss™-C SA]

00840067205334TrellOss™-C SA Straight Driver
00840067205327TrellOss™-C SA Straight Drill
00840067205310Lock Tool
00840067205976Ø4.0x18mm Screw, Self Tapping
00840067205969Ø4.0x16mm Screw, Self Tapping
00840067205952Ø4.0x14mm Screw, Self Tapping
00840067205945Ø4.0x12mm Screw, Self Tapping
00840067205938Ø3.5x18mm Screw, Self Tapping
00840067205921Ø3.5x16mm Screw, Self Tapping
00840067205914Ø3.5x14mm Screw, Self Tapping
00840067205907Ø3.5x12mm Screw, Self Tapping
00840067205891TrellOss-C SA 16Dx18Wx12H 6°
00840067205884TrellOss-C SA 16Dx18Wx11H 6°
00840067205877TrellOss-C SA 16Dx18Wx10H 6°
00840067205860TrellOss-C SA 16Dx18Wx9H 6°
00840067205853TrellOss-C SA 16Dx18Wx8H 6°
00840067205846TrellOss-C SA 16Dx18Wx7H 6°
00840067205839TrellOss-C SA 16Dx18Wx6H 6°
00840067205822TrellOss-C SA 16Dx18Wx5H 6°
00840067205815TrellOss-C SA 14Dx16Wx12H 6°
00840067205808TrellOss-C SA 14Dx16Wx11H 6°
00840067205792TrellOss-C SA 14Dx16Wx10H 6°
00840067205785TrellOss-C SA 14Dx16Wx9H 6°
00840067205778TrellOss-C SA 14Dx16Wx8H 6°
00840067205761TrellOss-C SA 14Dx16Wx7H 6°
00840067205754TrellOss-C SA 14Dx16Wx6H 6°
00840067205747TrellOss-C SA 14Dx16Wx5H 6°
00840067205730TrellOss-C SA 12Dx15Wx12H 6°
00840067205723TrellOss-C SA 12Dx15Wx11H 6°
00840067205716TrellOss-C SA 12Dx15Wx10H 6°
00840067205709TrellOss-C SA 12Dx15Wx9H 6°
00840067205693TrellOss-C SA 12Dx15Wx8H 6°
00840067205686TrellOss-C SA 12Dx15Wx7H 6°
00840067205679TrellOss-C SA 12Dx15Wx6H 6°
00840067205662TrellOss-C SA 12Dx15Wx5H 6°
00840067206218Rasp 16x18x12mm 6°
00840067206201Rasp 16x18x11mm 6°
00840067206195Rasp 16x18x10mm 6°
00840067206188Rasp 16x18x9mm 6°
00840067206171Rasp 16x18x8mm 6°
00840067206164Rasp 16x18x7mm 6°
00840067206157Rasp 16x18x6mm 6°
00840067206140Rasp 16x18x5mm 6°
00840067206133Rasp 14x16x12mm 6°
00840067206126Rasp 14x16x11mm 6°
00840067206119Rasp 14x16x10mm 6°
00840067206102Rasp 14x16x9mm 6°
00840067206096Rasp 14x16x8mm 6°
00840067206089Rasp 14x16x7mm 6°
00840067206072Rasp 14x16x6mm 6°

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.