TrellOss™-C SA

GUDID 00840067205846

TrellOss-C SA 16Dx18Wx7H 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 ID00840067205846
NIH Device Record Key029b66b5-7bc6-4aad-9d66-12497ab42782
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrellOss™-C SA
Version Model Number108N1607
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

Width18 Millimeter
Depth16 Millimeter
Height7 Millimeter
Angle6 degree
Width18 Millimeter
Depth16 Millimeter
Height7 Millimeter
Angle6 degree
Width18 Millimeter
Depth16 Millimeter
Height7 Millimeter
Angle6 degree
Width18 Millimeter
Depth16 Millimeter
Height7 Millimeter
Angle6 degree
Width18 Millimeter
Depth16 Millimeter
Height7 Millimeter
Angle6 degree
Width18 Millimeter
Depth16 Millimeter
Height7 Millimeter
Angle6 degree
Width18 Millimeter
Depth16 Millimeter
Height7 Millimeter
Angle6 degree
Width18 Millimeter
Depth16 Millimeter
Height7 Millimeter
Angle6 degree
Width18 Millimeter
Depth16 Millimeter
Height7 Millimeter
Angle6 degree
Width18 Millimeter
Depth16 Millimeter
Height7 Millimeter
Angle6 degree
Width18 Millimeter
Depth16 Millimeter
Height7 Millimeter
Angle6 degree
Width18 Millimeter
Depth16 Millimeter
Height7 Millimeter
Angle6 degree
Width18 Millimeter
Depth16 Millimeter
Height7 Millimeter
Angle6 degree
Width18 Millimeter
Depth16 Millimeter
Height7 Millimeter
Angle6 degree
Width18 Millimeter
Depth16 Millimeter
Height7 Millimeter
Angle6 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100840067205846 [Primary]
GS100840067205846 [Primary]
GS100840067205846 [Primary]
GS100840067205846 [Primary]
GS100840067205846 [Primary]
GS100840067205846 [Primary]
GS100840067205846 [Primary]
GS100840067205846 [Primary]
GS100840067205846 [Primary]
GS100840067205846 [Primary]
GS100840067205846 [Primary]
GS100840067205846 [Primary]
GS100840067205846 [Primary]
GS100840067205846 [Primary]
GS100840067205846 [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°

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