Carriage 8mm CI-CAR-A8

GUDID 00810017912476

Carriage 8mm

ELEVATION SPINE, INC.

Intervertebral-body internal spinal fixation system
Primary Device ID00810017912476
NIH Device Record Key77bb3e40-33f6-4ad6-b233-f587f5486688
Commercial Distribution StatusIn Commercial Distribution
Brand NameCarriage 8mm
Version Model NumberCI-CAR-A8
Catalog NumberCI-CAR-A8
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100810017912476 [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 Date2020-01-08
Device Publish Date2019-12-31

On-Brand Devices [Carriage 8mm]

00810017912476Carriage 8mm
00810017913459Carriage 8mm

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