EMERGE Micro Anterior Cervical Plate System 101-2L16

GUDID 00195860016190

2 LEVEL PLATE 16mm

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
Primary Device ID00195860016190
NIH Device Record Keyff0895dd-810d-487f-ab40-b5b2962c2ebe
Commercial Distribution StatusIn Commercial Distribution
Brand NameEMERGE Micro Anterior Cervical Plate System
Version Model Number101-2L16
Catalog Number101-2L16
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

Device Dimensions

Length16 Millimeter
Device Size Text, specify0
Length16 Millimeter
Device Size Text, specify0
Length16 Millimeter
Device Size Text, specify0
Length16 Millimeter
Device Size Text, specify0
Length16 Millimeter
Device Size Text, specify0
Length16 Millimeter
Device Size Text, specify0
Length16 Millimeter
Device Size Text, specify0
Length16 Millimeter
Device Size Text, specify0
Length16 Millimeter
Device Size Text, specify0
Length16 Millimeter
Device Size Text, specify0
Length16 Millimeter
Device Size Text, specify0
Length16 Millimeter
Device Size Text, specify0
Length16 Millimeter
Device Size Text, specify0
Length16 Millimeter
Device Size Text, specify0
Length16 Millimeter
Device Size Text, specify0
Length16 Millimeter
Device Size Text, specify0
Length16 Millimeter
Device Size Text, specify0
Length16 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100195860016190 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, fixation, spinal intervertebral body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00195860016190]

Moist Heat or Steam Sterilization

[00195860016190]

Moist Heat or Steam Sterilization

[00195860016190]

Moist Heat or Steam Sterilization

[00195860016190]

Moist Heat or Steam Sterilization

[00195860016190]

Moist Heat or Steam Sterilization

[00195860016190]

Moist Heat or Steam Sterilization

[00195860016190]

Moist Heat or Steam Sterilization

[00195860016190]

Moist Heat or Steam Sterilization

[00195860016190]

Moist Heat or Steam Sterilization

[00195860016190]

Moist Heat or Steam Sterilization

[00195860016190]

Moist Heat or Steam Sterilization

[00195860016190]

Moist Heat or Steam Sterilization

[00195860016190]

Moist Heat or Steam Sterilization

[00195860016190]

Moist Heat or Steam Sterilization

[00195860016190]

Moist Heat or Steam Sterilization

[00195860016190]

Moist Heat or Steam Sterilization

[00195860016190]

Moist Heat or Steam Sterilization

[00195860016190]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-21
Device Publish Date2022-06-10

On-Brand Devices [EMERGE Micro Anterior Cervical Plate System]

00195860016428DTS DRILL 20mm
00195860016411DTS DRILL 18mm
00195860016404DTS DRILL 16mm
00195860016398DTS DRILL 14mm
00195860016381DTS DRILL 12mm
00195860016374DTS DRILL 10mm
00195860016367INLINE INSERTER
00195860016350INLINE INSERTER DRAWBAR
001958600162682 LEVEL PLATE 30mm
001958600162512 LEVEL PLATE 28mm
001958600162442 LEVEL PLATE 26mm
001958600162372 LEVEL PLATE 24mm
001958600162202 LEVEL PLATE 22mm
001958600162132 LEVEL PLATE 20mm
001958600162062 LEVEL PLATE 18mm
001958600161902 LEVEL PLATE 16mm
001958600161832 LEVEL PLATE 14mm
001958600161761 LEVEL PLATE 12mm
001958600161691 LEVEL PLATE 11mm
001958600161521 LEVEL PLATE 10mm
001958600161451 LEVEL PLATE 9mm
001958600161381 LEVEL PLATE 8mm
001958600161211 LEVEL PLATE 7mm
001958600161141 LEVEL PLATE 6mm
001958600161071 LEVEL PLATE 5mm
00195860016435DTS GUIDE 9mm
00195860016343DTS GUIDE 12mm
00195860016336DTS GUIDE 11mm
00195860016329DTS GUIDE 10mm
00195860016305DTS GUIDE 8mm
00195860016299DTS GUIDE 7mm
00195860016282DTS GUIDE 6mm
00195860016275DTS GUIDE 5mm
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