IdentiTi

GUDID 00190376272771

CERVICAL INTERFIXATED TRIAL, 6 x 16 x 14 mm, 10°

ALPHATEC SPINE, INC.

Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial
Primary Device ID00190376272771
NIH Device Record Keya3a6731b-9411-4c2c-8c0f-5dcff675ecfb
Commercial Distribution StatusIn Commercial Distribution
Brand NameIdentiTi
Version Model Number135-10-06161410
Company DUNS602465783
Company NameALPHATEC SPINE, INC.
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 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(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com

Device Dimensions

Width16 Millimeter
Depth14 Millimeter
Height6 Millimeter
Angle10 degree
Width16 Millimeter
Depth14 Millimeter
Height6 Millimeter
Angle10 degree
Width16 Millimeter
Depth14 Millimeter
Height6 Millimeter
Angle10 degree
Width16 Millimeter
Depth14 Millimeter
Height6 Millimeter
Angle10 degree
Width16 Millimeter
Depth14 Millimeter
Height6 Millimeter
Angle10 degree
Width16 Millimeter
Depth14 Millimeter
Height6 Millimeter
Angle10 degree
Width16 Millimeter
Depth14 Millimeter
Height6 Millimeter
Angle10 degree
Width16 Millimeter
Depth14 Millimeter
Height6 Millimeter
Angle10 degree
Width16 Millimeter
Depth14 Millimeter
Height6 Millimeter
Angle10 degree
Width16 Millimeter
Depth14 Millimeter
Height6 Millimeter
Angle10 degree
Width16 Millimeter
Depth14 Millimeter
Height6 Millimeter
Angle10 degree
Width16 Millimeter
Depth14 Millimeter
Height6 Millimeter
Angle10 degree
Width16 Millimeter
Depth14 Millimeter
Height6 Millimeter
Angle10 degree
Width16 Millimeter
Depth14 Millimeter
Height6 Millimeter
Angle10 degree
Width16 Millimeter
Depth14 Millimeter
Height6 Millimeter
Angle10 degree
Width16 Millimeter
Depth14 Millimeter
Height6 Millimeter
Angle10 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100190376272771 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVEIntervertebral fusion device with integrated fixation, cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190376272771]

Moist Heat or Steam Sterilization


[00190376272771]

Moist Heat or Steam Sterilization


[00190376272771]

Moist Heat or Steam Sterilization


[00190376272771]

Moist Heat or Steam Sterilization


[00190376272771]

Moist Heat or Steam Sterilization


[00190376272771]

Moist Heat or Steam Sterilization


[00190376272771]

Moist Heat or Steam Sterilization


[00190376272771]

Moist Heat or Steam Sterilization


[00190376272771]

Moist Heat or Steam Sterilization


[00190376272771]

Moist Heat or Steam Sterilization


[00190376272771]

Moist Heat or Steam Sterilization


[00190376272771]

Moist Heat or Steam Sterilization


[00190376272771]

Moist Heat or Steam Sterilization


[00190376272771]

Moist Heat or Steam Sterilization


[00190376272771]

Moist Heat or Steam Sterilization


[00190376272771]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-08
Device Publish Date2021-03-31

On-Brand Devices [IdentiTi]

00190376182452IdentiTi Cervical Porous Ti Spacer, 8 x 14 x 12 mm, 7°
00190376182360IdentiTi Cervical Porous Ti Spacer, 7 x 18 x 16 mm, 10°
00190376182353IdentiTi Cervical Porous Ti Spacer, 7 x 18 x 16 mm, 7°
00190376182308IdentiTi Cervical Porous Ti Spacer, 7 x 16 x 14 mm, 10°
00190376182292IdentiTi Cervical Porous Ti Spacer, 7 x 16 x 14 mm, 7°
00190376182254IdentiTi Cervical Porous Ti Spacer, 6 x 18 x 16 mm, 10°
00190376182247IdentiTi Cervical Porous Ti Spacer, 6 x 18 x 16 mm, 7°
00190376182209IdentiTi Cervical Porous Ti Spacer, 6 x 16 x 14 mm, 10°
00190376182193IdentiTi Cervical Porous Ti Spacer, 6 x 16 x 14 mm, 7°
00190376182131IdentiTi Cervical Porous Ti Spacer, 6 x 14 x 12 mm, 7°
00190376182070IdentiTi Cervical Porous Ti Spacer, 5 x 18 x 16 mm, 7°
00190376182049IdentiTi Cervical Porous Ti Spacer, 5 x 16 x 14 mm, 7°
00190376180939IdentiTi Cervical Porous Ti Spacer, 9 x 18 x 16 mm, 10°
00190376180922IdentiTi Cervical Porous Ti Spacer, 9 x 18 x 16 mm, 7°
00190376180878IdentiTi Cervical Porous Ti Spacer, 9 x 16 x 14 mm, 10°
00190376180861IdentiTi Cervical Porous Ti Spacer, 9 x 16 x 14 mm, 7°
00190376180809IdentiTi Cervical Porous Ti Spacer, 9 x 14 x 12 mm, 7°
00190376180694IdentiTi Cervical Porous Ti Spacer, 8 x 18 x 16 mm, 10°
00190376180687IdentiTi Cervical Porous Ti Spacer, 8 x 18 x 16 mm, 7°
00190376180632IdentiTi Cervical Porous Ti Spacer, 8 x 16 x 14 mm, 10°
00190376180625IdentiTi Cervical Porous Ti Spacer, 8 x 16 x 14 mm, 7°
00190376180564IdentiTi Cervical Porous Ti Spacer, 7 x 14 x 12 mm, 7°
00190376180465IdentiTi Cervical Porous Ti Spacer, 5 x 14 x 12 mm, 7°
00190376218625IDENTITi ALIF POROUS Ti SPACER, SW, 7 x 38 x 28 mm, 10°
00190376218601IDENTITi ALIF POROUS Ti SPACER, SW, 6 x 38 x 28 mm, 30°
00190376218595IDENTITi ALIF POROUS Ti SPACER, SW, 6 x 38 x 28 mm, 20°
00190376218588IDENTITI ALIF POROUS TI SPACER, SW, 13 X 38 X 28 MM, 10°
00190376218571IDENTITI ALIF POROUS TI SPACER, SW, 12 X 34 X 24 MM, 15°
00190376218564IDENTITI ALIF POROUS TI SPACER, SW, 12 X 34 X 24 MM, 10°
00190376218540IDENTITi ALIF POROUS Ti SPACER, SW, 11 x 38 x 28 mm, 15°
00190376218533IDENTITi ALIF POROUS Ti SPACER, SW, 11 x 38 x 28 mm, 10°
00190376218519IDENTITi ALIF POROUS Ti SPACER, SW, 10 x 34 x 24 mm, 15°
00190376218502IDENTITi ALIF POROUS Ti SPACER, SW, 10 x 34 x 24 mm, 10°
00190376218472IDENTITi ALIF POROUS Ti SPACER, SW, 9 x 38 x 28 mm, 15°
00190376218465IDENTITi ALIF POROUS Ti SPACER, SW, 9 x 38 x 28 mm, 10°
00190376218441IDENTITi ALIF POROUS Ti SPACER, SW, 8 x 38 x 28 mm, 30°
00190376218434IDENTITi ALIF POROUS Ti SPACER, SW, 8 x 38 x 28 mm, 20°
00190376218427IDENTITi ALIF POROUS Ti SPACER, SW, 8 x 34 x 24 mm, 30°
00190376218410IDENTITi ALIF POROUS Ti SPACER, SW, 8 x 34 x 24 mm, 20°
00190376218403IDENTITi ALIF POROUS Ti SPACER, SW, 8 x 34 x 24 mm, 15°
00190376218397IDENTITi ALIF POROUS Ti SPACER, SW, 8 x 34 x 24 mm, 10°
00190376218366IDENTITi ALIF POROUS Ti SPACER, SW, 7 x 38 x 28 mm, 15°
00190376218359IDENTITi ALIF POROUS Ti SPACER, SW, 6 x 34 x 24 mm, 30°
00190376218342IDENTITi ALIF POROUS Ti SPACER, SW, 6 x 34 x 24 mm, 20°
00190376218335IDENTITi ALIF POROUS Ti SPACER, SW, 6 x 34 x 24 mm, 15°
00190376218328IDENTITi ALIF POROUS Ti SPACER, SW, 6 x 34 x 24 mm, 10°
00190376218304IDENTITi ALIF POROUS Ti SPACER, SW, 5 x 38 x 28 mm, 15°
00190376218298IDENTITi ALIF POROUS Ti SPACER, SW, 5 x 38 x 28 mm, 10°
00190376218281IDENTITi ALIF POROUS Ti SPACER, SW, 4 x 38 x 28 mm, 30°
00190376218274IDENTITi ALIF POROUS Ti SPACER, SW, 4 x 38 x 28 mm, 20°

Trademark Results [IdentiTi]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IDENTITI
IDENTITI
88469099 not registered Live/Pending
Identiti Resources, Ltd.
2019-06-11
IDENTITI
IDENTITI
77343392 3556238 Live/Registered
ISON DISTRIBUTION, LTD
2007-12-04

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.