Skye Cervical Plate System CP281

GUDID 00195860009901

28mm 1 Level Plate

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
Primary Device ID00195860009901
NIH Device Record Key1ff97c25-0be2-4ea1-848d-50c6a1ee7525
Commercial Distribution StatusIn Commercial Distribution
Brand NameSkye Cervical Plate System
Version Model NumberCP281
Catalog NumberCP281
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

Device Dimensions

Length28 Millimeter
Device Size Text, specify0
Length28 Millimeter
Device Size Text, specify0
Length28 Millimeter
Device Size Text, specify0
Length28 Millimeter
Device Size Text, specify0
Length28 Millimeter
Device Size Text, specify0
Length28 Millimeter
Device Size Text, specify0
Length28 Millimeter
Device Size Text, specify0
Length28 Millimeter
Device Size Text, specify0
Length28 Millimeter
Device Size Text, specify0
Length28 Millimeter
Device Size Text, specify0
Length28 Millimeter
Device Size Text, specify0
Length28 Millimeter
Device Size Text, specify0
Length28 Millimeter
Device Size Text, specify0
Length28 Millimeter
Device Size Text, specify0
Length28 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100195860009901 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, fixation, spinal intervertebral body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00195860009901]

Moist Heat or Steam Sterilization


[00195860009901]

Moist Heat or Steam Sterilization


[00195860009901]

Moist Heat or Steam Sterilization


[00195860009901]

Moist Heat or Steam Sterilization


[00195860009901]

Moist Heat or Steam Sterilization


[00195860009901]

Moist Heat or Steam Sterilization


[00195860009901]

Moist Heat or Steam Sterilization


[00195860009901]

Moist Heat or Steam Sterilization


[00195860009901]

Moist Heat or Steam Sterilization


[00195860009901]

Moist Heat or Steam Sterilization


[00195860009901]

Moist Heat or Steam Sterilization


[00195860009901]

Moist Heat or Steam Sterilization


[00195860009901]

Moist Heat or Steam Sterilization


[00195860009901]

Moist Heat or Steam Sterilization


[00195860009901]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-10
Device Publish Date2021-06-02

On-Brand Devices [Skye Cervical Plate System]

00195860010587Instrument Tray 1
00195860010600Fixed / Variable Screw Caddy
00195860010594Plate Caddy
00195860010570Skye Tray Lid
00195860010563Dia 2.0mm x 17mm
00195860010556Dia 2.0mm x 15mm
00195860010549Dia 2.0mm x 13mm
00195860010532Plate Holder
00195860010525Screw Driver (w/handle)
00195860010518Cover Turning Driver (w/handle)
00195860010501Fixed Drill Guide
00195860010495Variable Drill Guide
00195860010488Screw Driver
00195860010471Awl
00195860010464Cover Turning Driver
00195860010457Cervical Plate Fixation Pin
00195860010440Dia 4.25mm x 18mm Variable
00195860010433Dia 4.25mm x 16mm Variable
00195860010426Dia 4.25mm x 14mm Variable
00195860010419Dia 4.25mm x 12mm Variable
00195860010402Dia 3.75mm x 18mm Variable
00195860010396Dia 3.75mm x 16mm Variable
00195860010389Dia 3.75mm x 14mm Variable
00195860010372Dia 3.75mm x 12mm Variable
00195860010365Dia 4.25mm x 18mm Fixed
00195860010358Dia 4.25mm x 16mm Fixed
00195860010341Dia 4.25mm x 14mm Fixed
00195860010334Dia 4.25mm x 12mm Fixed
00195860010327Dia 3.75mm x 18mm Fixed
00195860010310Dia 3.75mm x 16mm Fixed
00195860010303Dia 3.75mm x 14mm Fixed
00195860010297Dia 3.75mm x 12mm Fixed
00195860010280110mm 5 Level Plate
00195860010273105mm 5 Level Plate
00195860010266100mm 5 Level Plate
0019586001025995mm 5 Level Plate
0019586001024290mm 5 Level Plate
0019586001023585mm 5 Level Plate
0019586001022880mm 5 Level Plate
0019586001021175mm 5 Level Plate
0019586001020484mm 4 Level Plate
0019586001019880mm 4 Level Plate
0019586001018176mm 4 Level Plate
0019586001017472mm 4 Level Plate
0019586001016768mm 4 Level Plate
0019586001015064mm 4 Level Plate
0019586001014360mm 4 Level Plate
0019586001013655mm 4 Level Plate
0019586001012950mm 4 Level Plate
0019586001011271mm 3 Level Plate

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