Novel Spinal Spacer System

GUDID 00844856064263

Novel LCC Titanium, 8x20x10mm Flat

ALPHATEC SPINE, INC.

Metallic spinal fusion cage, non-sterile

Primary Device ID	00844856064263
NIH Device Record Key	4f235f7d-4f5b-4adf-8aa7-52aca0832ea2
Commercial Distribution Status	In Commercial Distribution
Brand Name	Novel Spinal Spacer System
Version Model Number	64101-010
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	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)494-6840
Email	mfunk@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

Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Length	20 Millimeter
Height	10 Millimeter
Width	8 Millimeter
Length	20 Millimeter
Height	10 Millimeter
Width	8 Millimeter
Length	20 Millimeter
Height	10 Millimeter
Width	8 Millimeter
Length	20 Millimeter
Height	10 Millimeter
Width	8 Millimeter
Length	20 Millimeter
Height	10 Millimeter
Width	8 Millimeter
Length	20 Millimeter
Height	10 Millimeter
Width	8 Millimeter
Length	20 Millimeter
Height	10 Millimeter
Width	8 Millimeter
Length	20 Millimeter
Height	10 Millimeter
Width	8 Millimeter
Length	20 Millimeter
Height	10 Millimeter
Width	8 Millimeter
Length	20 Millimeter
Height	10 Millimeter
Width	8 Millimeter
Length	20 Millimeter
Height	10 Millimeter
Width	8 Millimeter
Length	20 Millimeter
Height	10 Millimeter
Width	8 Millimeter
Length	20 Millimeter
Height	10 Millimeter
Width	8 Millimeter
Length	20 Millimeter
Height	10 Millimeter
Width	8 Millimeter
Length	20 Millimeter
Height	10 Millimeter
Width	8 Millimeter
Length	20 Millimeter
Height	10 Millimeter
Width	8 Millimeter
Length	20 Millimeter
Height	10 Millimeter
Width	8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844856064263 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K042201

FDA Product Code

MQP	SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00844856064263]

Moist Heat or Steam Sterilization

[00844856064263]

Moist Heat or Steam Sterilization

[00844856064263]

Moist Heat or Steam Sterilization

[00844856064263]

Moist Heat or Steam Sterilization

[00844856064263]

Moist Heat or Steam Sterilization

[00844856064263]

Moist Heat or Steam Sterilization

[00844856064263]

Moist Heat or Steam Sterilization

[00844856064263]

Moist Heat or Steam Sterilization

[00844856064263]

Moist Heat or Steam Sterilization

[00844856064263]

Moist Heat or Steam Sterilization

[00844856064263]

Moist Heat or Steam Sterilization

[00844856064263]

Moist Heat or Steam Sterilization

[00844856064263]

Moist Heat or Steam Sterilization

[00844856064263]

Moist Heat or Steam Sterilization

[00844856064263]

Moist Heat or Steam Sterilization

[00844856064263]

Moist Heat or Steam Sterilization

[00844856064263]

Moist Heat or Steam Sterilization

[00844856064263]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2015-08-31

On-Brand Devices [Novel Spinal Spacer System]

00844856066861	Novel SD, Self Distracting PEEK Cage, Wide, Novel, L, 20 mm
00844856066854	Novel SD, Self Distracting PEEK Cage, Wide, Novel, L, 19 mm
00844856066847	Novel SD, Self Distracting PEEK Cage, Wide, Novel, L, 18 mm
00844856066830	Novel SD, Self Distracting PEEK Cage, Wide, Novel, L, 17 mm
00844856066823	Novel SD, Self Distracting PEEK Cage, Wide, Novel, L, 16 mm
00844856066816	Novel SD, Self Distracting PEEK Cage, Wide, Novel, L, 8 mm
00844856066809	Novel SD, Self Distracting PEEK Cage, Wide, Novel, M, 20 mm
00844856066793	Novel SD, Self Distracting PEEK Cage, Wide, Novel, M, 19 mm
00844856066786	Novel SD, Self Distracting PEEK Cage, Wide, Novel, M, 18 mm
00844856066779	Novel SD, Self Distracting PEEK Cage, Wide, Novel, M, 17 mm
00844856066762	Novel SD, Self Distracting PEEK Cage, Wide, Novel, M, 16 mm
00844856066755	Novel SD, Self Distracting PEEK Cage, Wide, Novel, M, 8 mm
00844856066748	Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 20 mm
00844856066731	Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 19 mm
00844856066724	Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 18 mm
00844856066717	Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 17 mm
00844856066700	Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 16 mm
00844856066694	Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 15 mm
00844856066687	Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 14 mm
00844856066670	Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 13 mm
00844856066663	Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 12 mm
00844856066656	Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 11 mm
00844856066649	Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 10 mm
00844856066632	Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 9 mm
00844856066625	Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 8 mm
00844856066601	Novel SD, Self Distracting PEEK Cage, Novel, Large, 20 mm
00844856066588	Novel SD, Self Distracting PEEK Cage, Novel, Large, 19 mm
00844856066564	Novel SD, Self Distracting PEEK Cage, Novel, Large, 18 mm
00844856066540	Novel SD, Self Distracting PEEK Cage, Novel, Large, 17 mm
00844856066526	Novel SD, Large, 16mm, PEEK
00844856066427	Self Distracting PEEK Cage, Novel, Medium, 20 mm
00844856066403	Self Distracting PEEK Cage, Novel, Medium, 19 mm
00844856066380	Self Distracting PEEK Cage, Novel, Medium, 18 mm
00844856066366	Self Distracting PEEK Cage, Novel, Medium, 17 mm
00844856066342	Novel SD, Medium, 16mm, PEEK
00844856066243	Novel SD,Self Distracting PEEK Cage, Novel, Small, 20 mm
00844856066229	Novel SD,Self Distracting PEEK Cage, Novel, Small, 19 mm
00844856066205	Novel SD,Self Distracting PEEK Cage, Novel, Small, 18 mm
00844856066182	Novel SD,Self Distracting PEEK Cage, Novel, Small, 17 mm
00844856066168	Novel SD, Small, 16mm, PEEK
00844856066076	Novel Cervical Spacer, 12 mm Large, 7deg Lordotic, Titanium
00844856066069	Novel Cervical Spacer, 11 mm Large, 7deg Lordotic, Titanium
00844856066052	Novel Cervical Spacer, 10 mm Large, 7deg Lordotic, Titanium
00844856066045	Novel Cervical Spacer, 9 mm Large, 7deg Lordotic, Titanium
00844856066038	Novel Cervical Spacer, 8 mm Large, 7deg Lordotic, Titanium
00844856066021	Novel Cervical Spacer, 7 mm Large, 7deg Lordotic, Titanium
00844856066014	Novel Cervical Spacer, 6 mm Large, 7deg Lordotic, Titanium
00844856066007	Novel Cervical Spacer, 5 mm Large, 7deg Lordotic, Titanium
00844856065994	Novel Cervical Spacer, 12 mm Large, 7deg Lordotic, PEEK
00844856065987	Novel Cervical Spacer, 11 mm Large, 7deg Lordotic, PEEK

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