Screw Carriage CI-CAR3-SC

GUDID 00810017914173

Screw Carriage

ELEVATION SPINE, INC.

Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system
Primary Device ID00810017914173
NIH Device Record Key127903de-7808-4599-90b2-2e60ca16398a
Commercial Distribution StatusIn Commercial Distribution
Brand NameScrew Carriage
Version Model NumberCI-CAR3-SC
Catalog NumberCI-CAR3-SC
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100810017914173 [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 Date2024-01-24
Device Publish Date2024-01-16

Devices Manufactured by ELEVATION SPINE, INC.

00810017913411 - SABER-C RASP2024-01-29 Saber-C Rasp, 12x15x5, 6 deg.
00810017913428 - SABER-C RASP2024-01-29 Saber-C Rasp, 14x17x5, 6 deg
00810017913497 - SABER-C BASE WITH INSERT TRAY2024-01-29 SABER-C BASE WITH INSERT TRAY
00810017913435 - Carriage 5-6mm2024-01-26 Carriage 5-6mm
00810017913442 - Carriage 7mm2024-01-26 Carriage 7mm
00810017913459 - Carriage 8mm2024-01-26 Carriage 8mm
00810017913466 - Carriage 9mm2024-01-26 Carriage 9mm
00810017913473 - Carriage 10mm2024-01-26 Carriage 10mm
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