ATEC Porous Ti Interbody System

GUDID 00190376100463

Cervical Trial, 4 x 16 x 14 - 0°

ALPHATEC SPINE, INC.

Spinal implant trial

Primary Device ID	00190376100463
NIH Device Record Key	31129a76-af06-4569-a407-8696c2ccd89b
Commercial Distribution Status	In Commercial Distribution
Brand Name	ATEC Porous Ti Interbody System
Version Model Number	115-04161400
Company DUNS	602465783
Company Name	ALPHATEC SPINE, INC.
Device Count	1
DM Exempt	false
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	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
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

Device Dimensions

Length

14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376100463 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K183705

FDA Product Code

ODP	Intervertebral fusion device with bone graft, cervical

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00190376100463]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-03-10
Device Publish Date	2020-03-02

On-Brand Devices [ATEC Porous Ti Interbody System]

00190376160580	PO Offset Inserter
00190376159812	PO Inserter, 10 mm Bolstered Sleeve
00190376159805	PO Inserter, 12 mm Impaction Sleeve
00190376151182	PO Inserter, 10 mm Impaction Sleeve
00190376151175	PO Inserter
00190376151137	PO Trial, 12P x 13A x 12W x 30L , 5°
00190376151120	PO Trial, 10P x 11A x 12W x 30L , 5°
00190376151113	PO Trial, 8P x 9A x 12W x 30L , 5°
00190376148953	PO Trial, 12P x 14A x 10W x 30L , 10°
00190376148946	PO Trial, 10P x 12A x 10W x 30L , 10°
00190376148939	PO Trial, 8P x 10A x 10W x 30L , 10°
00190376148922	PO Trial, 12P x 13A x 10W x 30L , 5°
00190376148915	PO Trial, 10P x 11A x 10W x 30L , 5°
00190376148908	PO Trial, 8P x 9A x 10W x 30L , 5°
00190376148892	PO Trial, 12P x 14A x 10W x 25L , 10°
00190376148885	PO Trial, 10P x 12A x 10W x 25L , 10°
00190376148878	PO Trial, 8P x 10A x 10W x 25L , 10°
00190376148861	PO Trial, 12P x 13A x 10W x 25L , 5°
00190376148854	PO Trial, 10P x 11A x 10W x 25L , 5°
00190376148847	PO Trial, 8P x 9A x 10W x 25L , 5°
00190376146591	ATEC POROUS Ti PC, INSERTER, OFFSET
00190376146577	ATEC POROUS Ti PC, INSERTER, AXIAL
00190376116532	ATEC Porous Ti PS, Inserter, Offset
00190376116518	ATEC Porous Ti PS, Inserter, Axial
00190376116389	PC Trial, 9 x 10 x 30 mm - 15°
00190376116365	PC Trial, 7 x 10 x 30 mm - 15°
00190376116266	PC Trial, 10 x 10 x 30 mm - 10°
00190376116259	PC Trial, 9 x 10 x 30 mm - 10°
00190376116242	PC Trial, 8 x 10 x 30 - 10°
00190376116235	PC Trial, 7 x 10 x 30 - 10°
00190376116136	PC Trial, 11 x 10 x 30 - 5°
00190376116129	PC Trial, 10 x 10 x 30 - 5°
00190376116112	PC Trial, 9 x 10 x 30 - 5°
00190376116105	PC Trial, 8 x 10 x 30 - 5°
00190376102887	Cervical Trial, 12 x 22 x 19 - 15°
00190376102870	Cervical Trial, 12 x 22 x 19 - 12°
00190376102863	Cervical Trial, 12 x 22 x 19 - 10°
00190376102856	Cervical Trial, 12 x 22 x 19 - 7°
00190376102849	Cervical Trial, 12 x 22 x 19 - 5°
00190376102832	Cervical Trial, 12 x 22 x 19 - 0°
00190376102825	Cervical Trial, 12 x 20 x 18 - 15°
00190376102818	Cervical Trial, 10 x 22 x 19 - 5°
00190376102801	Cervical Trial, 10 x 22 x 19 - 0°
00190376102795	Cervical Trial, 10 x 20 x 18 - 15°
00190376102788	Cervical Trial, 10 x 20 x 18 - 12°
00190376102771	Cervical Trial, 10 x 20 x 18 - 10°
00190376102764	Cervical Trial, 10 x 20 x 18 - 7°
00190376102757	Cervical Trial, 10 x 20 x 18 - 5°
00190376102740	Cervical Trial, 10 x 20 x 18 - 0°
00190376102733	Cervical Trial, 10 x 18 x 16 - 15°