General Instruments

GUDID 00840180501993

Cervical Trial Rasp w/o Stop - 10x14x12, 7degree

ALPHATEC SPINE, INC.

Spinal implant trial

Primary Device ID	00840180501993
NIH Device Record Key	b5c06148-f9d7-40c6-9da2-6e197f7ee485
Commercial Distribution Status	In Commercial Distribution
Brand Name	General Instruments
Version Model Number	CI-10275-10141207
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
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
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	12 Millimeter
Angle	7 degree
Height	10 Millimeter
Width	14 Millimeter
Depth	12 Millimeter
Angle	7 degree
Height	10 Millimeter
Width	14 Millimeter
Depth	12 Millimeter
Angle	7 degree
Height	10 Millimeter
Width	14 Millimeter
Depth	12 Millimeter
Angle	7 degree
Height	10 Millimeter
Width	14 Millimeter
Depth	12 Millimeter
Angle	7 degree
Height	10 Millimeter
Width	14 Millimeter
Depth	12 Millimeter
Angle	7 degree
Height	10 Millimeter
Width	14 Millimeter
Depth	12 Millimeter
Angle	7 degree
Height	10 Millimeter
Width	14 Millimeter
Depth	12 Millimeter
Angle	7 degree
Height	10 Millimeter
Width	14 Millimeter
Depth	12 Millimeter
Angle	7 degree
Height	10 Millimeter
Width	14 Millimeter
Depth	12 Millimeter
Angle	7 degree
Height	10 Millimeter
Width	14 Millimeter
Depth	12 Millimeter
Angle	7 degree
Height	10 Millimeter
Width	14 Millimeter
Depth	12 Millimeter
Angle	7 degree
Height	10 Millimeter
Width	14 Millimeter
Depth	12 Millimeter
Angle	7 degree
Height	10 Millimeter
Width	14 Millimeter
Depth	12 Millimeter
Angle	7 degree
Height	10 Millimeter
Width	14 Millimeter
Depth	12 Millimeter
Angle	7 degree
Height	10 Millimeter
Width	14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840180501993 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K202812
Premarket Notification: K203742

FDA Product Code

ODP	Intervertebral fusion device with bone graft, cervical
OVE	Intervertebral fusion device with integrated fixation, cervical

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00840180501993]

Moist Heat or Steam Sterilization

[00840180501993]

Moist Heat or Steam Sterilization

[00840180501993]

Moist Heat or Steam Sterilization

[00840180501993]

Moist Heat or Steam Sterilization

[00840180501993]

Moist Heat or Steam Sterilization

[00840180501993]

Moist Heat or Steam Sterilization

[00840180501993]

Moist Heat or Steam Sterilization

[00840180501993]

Moist Heat or Steam Sterilization

[00840180501993]

Moist Heat or Steam Sterilization

[00840180501993]

Moist Heat or Steam Sterilization

[00840180501993]

Moist Heat or Steam Sterilization

[00840180501993]

Moist Heat or Steam Sterilization

[00840180501993]

Moist Heat or Steam Sterilization

[00840180501993]

Moist Heat or Steam Sterilization

[00840180501993]

Moist Heat or Steam Sterilization

[00840180501993]

Moist Heat or Steam Sterilization

[00840180501993]

Moist Heat or Steam Sterilization

[00840180501993]

Moist Heat or Steam Sterilization

[00840180501993]

Moist Heat or Steam Sterilization

[00840180501993]

Moist Heat or Steam Sterilization

[00840180501993]

Moist Heat or Steam Sterilization

[00840180501993]

Moist Heat or Steam Sterilization

[00840180501993]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-08-05
Device Publish Date	2021-07-28

On-Brand Devices [General Instruments]

00811801037276	Penfield 4 w/Larger Handle
00811801039973	Ball Tip Probe, Rod Holder
00811801038204	Heavy Guidewire Comb
00840180501221	SHARP COBB, UP-ANGLED 22MM
00840180501214	SHARP COBB, STRAIGHT 22MM
00840180501207	SHARP COBB, DOWN-ANGLED 18MM
00840180501191	SHARP COBB, UP-ANGLED 18MM
00840180501184	SHARP COBB, STRAIGHT 18MM
00840180501177	SHARP COBB, UP-ANGLED 12MM
00840180501160	SHARP COBB, STRAIGHT 12MM
00840180501153	5mm Extra Wide Saddle Removal Tool
00840180501146	Larger ALIF Tamp w/Teeth
00840180501139	Size 4 Curette - Down 60Deg
00840180501122	Size 2 Curette - 15Deg Up
00840180501115	Closed Tulip Screwdriver
00840180501108	Battalion, LLIF, 4th Blade w/ Large Handle, 12mm x 230mm
00840180501092	Battalion, LLIF, 4th Blade w/ Large Handle, 12mm x 190mm
00840180501085	Battalion, LLIF, 4th Blade w/ Large Handle, 8mm x 230mm
00840180501078	Battalion, LLIF, 4th Blade w/ Large Handle, 8mm x 190mm
00840180501061	Tamp w/ Center Pin, Straight
00840180501054	Suction Cobb
00840180501047	LIF Cup Curette, Offset Up Angled, Size 0
00840180501030	Long Plate Holder
00840180501023	Set Screw Inserter - 4" shorter
00840180501016	Modular Compress-Distract Rack - Diener QC
00840180501009	Stab and Grab Screwdriver - Short, no clip
00840180500996	90 degree Head Turner - Extra long, large diameter
00840180500989	Slap Hammer Adapter, Large Battalion Backend
00840180500972	Slap Hammer Adapter, 1/4" Sq
00840180500965	ACDF Nerve Hook
00840180500958	Gear Shift Probe w/Radel Ball Handle
00840180500941	STIRRUP SCRAPER, UP-ANGLED DOUBLE SIDE - 18MM
00840180500934	STIRRUP SCRAPER, UP-ANGLED DOUBLE SIDE - 16MM
00840180500927	STIRRUP SCRAPER, UP-ANGLED DOUBLE SIDE - 14MM
00840180500910	STIRRUP SCRAPER, UP-ANGLED DOUBLE SIDE - 12MM
00840180500903	STIRRUP SCRAPER, SINGLE SIDE - 18MM
00840180500897	STIRRUP SCRAPER, SINGLE SIDE - 16MM
00840180500880	STIRRUP SCRAPER, SINGLE SIDE - 14MM
00840180500873	STIRRUP SCRAPER, SINGLE SIDE - 12MM
00840180500866	STIRRUP SCRAPER, UP-ANGLED - 18MM
00840180500859	STIRRUP SCRAPER, UP-ANGLED - 16MM
00840180500842	STIRRUP SCRAPER, UP-ANGLED - 14MM
00840180500835	STIRRUP SCRAPER, UP-ANGLED - 12MM
00840180500828	STIRRUP SCRAPER - 18MM
00840180500811	STIRRUP SCRAPER - 16MM
00840180500804	STIRRUP SCRAPER - 14MM
00840180500798	STIRRUP SCRAPER - 12MM
00840180500781	Distractor, 10x5x25mm-15°
00840180500774	Distractor, 9x5x25mm-15°
00840180500767	Distractor, 8x5x25mm-15°

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