EMERGE Anterior Cervical Plate System 100-1L22

GUDID 00195860012765

1 LEVEL PLATE 22 mm

Evolution Spine LLC

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable
Primary Device ID00195860012765
NIH Device Record Key735be94d-f4a7-48cb-8d66-0f7fbcec013b
Commercial Distribution StatusIn Commercial Distribution
Brand NameEMERGE Anterior Cervical Plate System
Version Model Number100-1L22
Catalog Number100-1L22
Company DUNS116940934
Company NameEvolution Spine LLC
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com

Device Dimensions

Length22 Millimeter
Device Size Text, specify0
Length22 Millimeter
Device Size Text, specify0
Length22 Millimeter
Device Size Text, specify0
Length22 Millimeter
Device Size Text, specify0
Length22 Millimeter
Device Size Text, specify0
Length22 Millimeter
Device Size Text, specify0
Length22 Millimeter
Device Size Text, specify0
Length22 Millimeter
Device Size Text, specify0
Length22 Millimeter
Device Size Text, specify0
Length22 Millimeter
Device Size Text, specify0
Length22 Millimeter
Device Size Text, specify0
Length22 Millimeter
Device Size Text, specify0
Length22 Millimeter
Device Size Text, specify0
Length22 Millimeter
Device Size Text, specify0
Length22 Millimeter
Device Size Text, specify0
Length22 Millimeter
Device Size Text, specify0
Length22 Millimeter
Device Size Text, specify0
Length22 Millimeter
Device Size Text, specify0
Length22 Millimeter
Device Size Text, specify0
Length22 Millimeter
Device Size Text, specify0
Length22 Millimeter
Device Size Text, specify0
Length22 Millimeter
Device Size Text, specify0
Length22 Millimeter
Device Size Text, specify0
Length22 Millimeter
Device Size Text, specify0
Length22 Millimeter
Device Size Text, specify0
Length22 Millimeter
Device Size Text, specify0
Length22 Millimeter
Device Size Text, specify0
Length22 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100195860012765 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, fixation, spinal intervertebral body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00195860012765]

Moist Heat or Steam Sterilization


[00195860012765]

Moist Heat or Steam Sterilization


[00195860012765]

Moist Heat or Steam Sterilization


[00195860012765]

Moist Heat or Steam Sterilization


[00195860012765]

Moist Heat or Steam Sterilization


[00195860012765]

Moist Heat or Steam Sterilization


[00195860012765]

Moist Heat or Steam Sterilization


[00195860012765]

Moist Heat or Steam Sterilization


[00195860012765]

Moist Heat or Steam Sterilization


[00195860012765]

Moist Heat or Steam Sterilization


[00195860012765]

Moist Heat or Steam Sterilization


[00195860012765]

Moist Heat or Steam Sterilization


[00195860012765]

Moist Heat or Steam Sterilization


[00195860012765]

Moist Heat or Steam Sterilization


[00195860012765]

Moist Heat or Steam Sterilization


[00195860012765]

Moist Heat or Steam Sterilization


[00195860012765]

Moist Heat or Steam Sterilization


[00195860012765]

Moist Heat or Steam Sterilization


[00195860012765]

Moist Heat or Steam Sterilization


[00195860012765]

Moist Heat or Steam Sterilization


[00195860012765]

Moist Heat or Steam Sterilization


[00195860012765]

Moist Heat or Steam Sterilization


[00195860012765]

Moist Heat or Steam Sterilization


[00195860012765]

Moist Heat or Steam Sterilization


[00195860012765]

Moist Heat or Steam Sterilization


[00195860012765]

Moist Heat or Steam Sterilization


[00195860012765]

Moist Heat or Steam Sterilization


[00195860012765]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-09
Device Publish Date2021-11-01

On-Brand Devices [EMERGE Anterior Cervical Plate System]

00195860015810EMERGE System Tag
00195860015766Implant Tray
00195860015759Fixed Screw Caddy
00195860015742Variable Screw Caddy
001958600157355 Level Caddy
001958600157284 Level Caddy
001958600157113 Level Caddy
001958600157041/2 Level Caddy
00195860015698Instrument Tray 1
00195860015681Outer Tub Tag
00195860015643Tapered Driver Sleeve
00195860015605Tapered Sleeve Driver Size 10
00195860015599Punch Awl
00195860015476SHORT PULL HANDLE A/O
00195860015469RATCHETING HANDLE A/O
00195860015452PLATE BENDER
00195860014899REUSABLE DRILL 20 mm
00195860014882REUSABLE DRILL 18 mm
00195860014875REUSABLE DRILL 16 mm
00195860014868REUSABLE DRILL 14 mm
00195860014851REUSABLE DRILL 12 mm
00195860014844REUSABLE DRILL 10 mm
00195860014837REUSABLE AWL 20 mm
00195860014820REUSABLE AWL 18 mm
00195860014813REUSABLE AWL 16 mm
00195860014806REUSABLE AWL 14 mm
00195860014790REUSABLE AWL 12 mm
00195860014776CERVICAL AWL 10 mm
00195860014769FIXED TAPPING CERVICAL SCREW DIA 4.25 X 26 mm
00195860014752FIXED TAPPING CERVICAL SCREW DIA 4.25 X 24 mm
00195860014745FIXED TAPPING CERVICAL SCREW DIA 4.25 X 22 mm
00195860014738FIXED TAPPING CERVICAL SCREW DIA 4.25 X 20 mm
00195860014721FIXED TAPPING CERVICAL SCREW DIA 4.25 X 18 mm
00195860014714FIXED TAPPING CERVICAL SCREW DIA 4.25 X 16 mm
00195860014707FIXED TAPPING CERVICAL SCREW DIA 4.25 X 14 mm
00195860014691FIXED TAPPING CERVICAL SCREW DIA 4.25 X 12 mm
00195860014684FIXED TAPPING CERVICAL SCREW DIA 4.25 X 10 mm
00195860014677FIXED TAPPING CERVICAL SCREW DIA 4.00 X 26 mm
00195860014660FIXED TAPPING CERVICAL SCREW DIA 4.00 X 24 mm
00195860014653FIXED TAPPING CERVICAL SCREW DIA 4.00 X 22 mm
00195860014646FIXED TAPPING CERVICAL SCREW DIA 4.00 X 20 mm
00195860014639FIXED TAPPING CERVICAL SCREW DIA 4.00 X 18 mm
00195860014622FIXED TAPPING CERVICAL SCREW DIA 4.00 X 16 mm
00195860014615FIXED TAPPING CERVICAL SCREW DIA 4.00 X 14 mm
00195860014608FIXED TAPPING CERVICAL SCREW DIA 4.00 X 12 mm
00195860014592FIXED TAPPING CERVICAL SCREW DIA 4.00 X 10 mm
00195860014585FIXED TAPPING CERVICAL SCREW DIA 3.75 X 26 mm
00195860014578FIXED TAPPING CERVICAL SCREW DIA 3.75 X 24 mm
00195860014561FIXED TAPPING CERVICAL SCREW DIA 3.75 X 22 mm
00195860014554FIXED TAPPING CERVICAL SCREW DIA 3.75 X 20 mm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.