Spikes Implants CQ-12

GUDID 00810017910052

Saber-C Spikes (No Carriage)

ELEVATION SPINE, INC.

Intervertebral-body internal spinal fixation system
Primary Device ID00810017910052
NIH Device Record Key764d2549-9e49-4560-ba9f-43f90a868e29
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpikes Implants
Version Model NumberCQ-12
Catalog NumberCQ-12
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
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
GS100810017910052 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-19
Device Publish Date2019-11-11

Devices Manufactured by ELEVATION SPINE, INC.

00810017914777 - Double Ended Rasp/Trial 12x15x5, 6°2025-04-07 Double Ended Rasp/Trial 12x15x5, 6°
00810017914784 - Double Ended Rasp/Trial 12x15x6, 6°2025-04-07 Double Ended Rasp/Trial 12x15x6, 6°
00810017914791 - Double Ended Rasp/Trial 12x15x7, 6°2025-04-07 Double Ended Rasp/Trial 12x15x7, 6°
00810017914807 - Double Ended Rasp/Trial 12x15x8, 6°2025-04-07 Double Ended Rasp/Trial 12x15x8, 6°
00810017914814 - Double Ended Rasp/Trial 12x15x9, 6°2025-04-07 Double Ended Rasp/Trial 12x15x9, 6°
00810017914821 - Double Ended Rasp/Trial 14x17x5, 6°2025-04-07 Double Ended Rasp/Trial 14x17x5, 6°
00810017914838 - Double Ended Rasp/Trial 14x17x6, 6°2025-04-07 Double Ended Rasp/Trial 14x17x6, 6°
00810017914845 - Double Ended Rasp/Trial 14x17x7, 6°2025-04-07 Double Ended Rasp/Trial 14x17x7, 6°

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