IdentiTi NanoTec

GUDID 00190376461274

IdentiTi NanoTec PS Porous Ti Spacer, 13 x 9 x 30 mm, 15°

ALPHATEC SPINE, INC.

Metallic spinal interbody fusion cage

Primary Device ID	00190376461274
NIH Device Record Key	a1cea24f-b3c2-479d-b2a0-eda143ac444d
Commercial Distribution Status	In Commercial Distribution
Brand Name	IdentiTi NanoTec
Version Model Number	120-PRO-13093015-S
Company DUNS	602465783
Company Name	ALPHATEC SPINE, INC.
Device Count	1
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com

Device Dimensions

Depth	30 Millimeter
Width	9 Millimeter
Angle	15 degree
Height	13 Millimeter
Depth	30 Millimeter
Width	9 Millimeter
Angle	15 degree
Height	13 Millimeter
Depth	30 Millimeter
Width	9 Millimeter
Angle	15 degree
Height	13 Millimeter
Depth	30 Millimeter
Width	9 Millimeter
Angle	15 degree
Height	13 Millimeter
Depth	30 Millimeter
Width	9 Millimeter
Angle	15 degree
Height	13 Millimeter
Depth	30 Millimeter
Width	9 Millimeter
Angle	15 degree
Height	13 Millimeter
Depth	30 Millimeter
Width	9 Millimeter
Angle	15 degree
Height	13 Millimeter
Depth	30 Millimeter
Width	9 Millimeter
Angle	15 degree
Height	13 Millimeter
Depth	30 Millimeter
Width	9 Millimeter
Angle	15 degree
Height	13 Millimeter
Depth	30 Millimeter
Width	9 Millimeter
Angle	15 degree
Height	13 Millimeter
Depth	30 Millimeter
Width	9 Millimeter
Angle	15 degree
Height	13 Millimeter
Depth	30 Millimeter
Width	9 Millimeter
Angle	15 degree
Height	13 Millimeter
Depth	30 Millimeter
Width	9 Millimeter
Angle	15 degree
Height	13 Millimeter
Depth	30 Millimeter
Width	9 Millimeter
Angle	15 degree
Height	13 Millimeter
Depth	30 Millimeter
Width	9 Millimeter
Angle	15 degree
Height	13 Millimeter
Depth	30 Millimeter
Width	9 Millimeter
Angle	15 degree
Height	13 Millimeter
Depth	30 Millimeter
Width	9 Millimeter
Angle	15 degree
Height	13 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376461274 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K222028

FDA Product Code

PHM	Intervertebral fusion device with bone graft, thoracic

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[00190376461274]

Radiation Sterilization

[00190376461274]

Radiation Sterilization

[00190376461274]

Radiation Sterilization

[00190376461274]

Radiation Sterilization

[00190376461274]

Radiation Sterilization

[00190376461274]

Radiation Sterilization

[00190376461274]

Radiation Sterilization

[00190376461274]

Radiation Sterilization

[00190376461274]

Radiation Sterilization

[00190376461274]

Radiation Sterilization

[00190376461274]

Radiation Sterilization

[00190376461274]

Radiation Sterilization

[00190376461274]

Radiation Sterilization

[00190376461274]

Radiation Sterilization

[00190376461274]

Radiation Sterilization

[00190376461274]

Radiation Sterilization

[00190376461274]

Radiation Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-08-24
Device Publish Date	2023-08-16

On-Brand Devices [IdentiTi NanoTec]

00190376364360	IDENTITi NANOTEC LIF POROUS Ti SPACER, 16 x 26 x 65 mm, 0°
00190376364353	IDENTITi NANOTEC LIF POROUS Ti SPACER, 16 x 26 x 60 mm, 0°
00190376364346	IDENTITi NANOTEC LIF POROUS Ti SPACER, 16 x 26 x 55 mm, 0°
00190376364339	IDENTITi NANOTEC LIF POROUS Ti SPACER, 16 x 26 x 50 mm, 0°
00190376364322	IDENTITi NANOTEC LIF POROUS Ti SPACER, 16 x 26 x 45 mm, 0°
00190376364315	IDENTITi NANOTEC LIF POROUS Ti SPACER, 16 x 26 x 40 mm, 0°
00190376364308	IDENTITi NANOTEC LIF POROUS Ti SPACER, 16 x 22 x 65 mm, 0°
00190376364292	IDENTITi NANOTEC LIF POROUS Ti SPACER, 16 x 22 x 60 mm, 0°
00190376364285	IDENTITi NANOTEC LIF POROUS Ti SPACER, 16 x 22 x 55 mm, 0°
00190376364278	IDENTITi NANOTEC LIF POROUS Ti SPACER, 16 x 22 x 50 mm, 0°
00190376364261	IDENTITi NANOTEC LIF POROUS Ti SPACER, 16 x 22 x 45 mm, 0°
00190376364254	IDENTITi NANOTEC LIF POROUS Ti SPACER, 16 x 22 x 40 mm, 0°
00190376364247	IDENTITi NANOTEC LIF POROUS Ti SPACER, 15 x 26 x 65 mm, 0°
00190376364230	IDENTITi NANOTEC LIF POROUS Ti SPACER, 15 x 26 x 60 mm, 0°
00190376364223	IDENTITi NANOTEC LIF POROUS Ti SPACER, 15 x 26 x 55 mm, 0°
00190376364216	IDENTITi NANOTEC LIF POROUS Ti SPACER, 15 x 26 x 50 mm, 0°
00190376364209	IDENTITi NANOTEC LIF POROUS Ti SPACER, 15 x 26 x 45 mm, 0°
00190376364193	IDENTITi NANOTEC LIF POROUS Ti SPACER, 15 x 26 x 40 mm, 0°
00190376364186	IDENTITi NANOTEC LIF POROUS Ti SPACER, 15 x 22 x 65 mm, 0°
00190376364179	IDENTITi NANOTEC LIF POROUS Ti SPACER, 15 x 22 x 60 mm, 0°
00190376364162	IDENTITi NANOTEC LIF POROUS Ti SPACER, 15 x 22 x 55 mm, 0°
00190376364155	IDENTITi NANOTEC LIF POROUS Ti SPACER, 15 x 22 x 50 mm, 0°
00190376364148	IDENTITi NANOTEC LIF POROUS Ti SPACER, 15 x 22 x 45 mm, 0°
00190376364131	IDENTITi NANOTEC LIF POROUS Ti SPACER, 15 x 22 x 40 mm, 0°
00190376364124	IDENTITi NANOTEC LIF-HL POROUS Ti SPACER, 14 x 26 x 65 mm, 20°
00190376364117	IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 65 mm, 15°
00190376364100	IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 65 mm, 10°
00190376364094	IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 65 mm, 5°
00190376364087	IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 65 mm, 0°
00190376364070	IDENTITi NANOTEC LIF-HL POROUS Ti SPACER, 14 x 26 x 60 mm, 20°
00190376364063	IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 60 mm, 15°
00190376364056	IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 60 mm, 10°
00190376364049	IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 60 mm, 5°
00190376364032	IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 60 mm, 0°
00190376364025	IDENTITi NANOTEC LIF-HL POROUS Ti SPACER, 14 x 26 x 55 mm, 20°
00190376364018	IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 55 mm, 15°
00190376364001	IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 55 mm, 10°
00190376363998	IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 55 mm, 5°
00190376363981	IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 55 mm, 0°
00190376363974	IDENTITi NANOTEC LIF-HL POROUS Ti SPACER, 14 x 26 x 50 mm, 20°
00190376363967	IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 50 mm, 15°
00190376363950	IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 50 mm, 10°
00190376363943	IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 50 mm, 5°
00190376363936	IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 50 mm, 0°
00190376363929	IDENTITi NANOTEC LIF-HL POROUS Ti SPACER, 14 x 26 x 45 mm, 20°
00190376363912	IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 45 mm, 15°
00190376363905	IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 45 mm, 10°
00190376363899	IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 45 mm, 5°
00190376363882	IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 45 mm, 0°
00190376363875	IDENTITi NANOTEC LIF-HL POROUS Ti SPACER, 14 x 26 x 40 mm, 20°