Spike Driver, 8-9mm CI-DRIVER3-SP-89

GUDID 00810017913558

Spike Driver, 8-9mm

ELEVATION SPINE, INC.

Intervertebral-body internal spinal fixation system
Primary Device ID00810017913558
NIH Device Record Key65f85d06-4e61-4173-a32d-d7a2d908e0de
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpike Driver, 8-9mm
Version Model NumberCI-DRIVER3-SP-89
Catalog NumberCI-DRIVER3-SP-89
Company DUNS085718404
Company NameELEVATION 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com
Phone844-415-0226
Emailinfo@elevationspine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810017913558 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-26
Device Publish Date2024-01-18

On-Brand Devices [Spike Driver, 8-9mm]

00810017913237Spike Driver, 8-9mm
00810017913558Spike Driver, 8-9mm

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