Vail ALIF Buttress Plate System BP132620

GUDID 00195860010686

26mm 20 Deg Buttress 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 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 ID00195860010686
NIH Device Record Keycc86ece3-798d-4425-8deb-042456c051af
Commercial Distribution StatusIn Commercial Distribution
Brand NameVail ALIF Buttress Plate System
Version Model NumberBP132620
Catalog NumberBP132620
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
Phone+1(214)682-8536
Emailinfo@evolutionspine.com

Device Dimensions

Length26 Millimeter
Angle20 degree
Length26 Millimeter
Angle20 degree
Length26 Millimeter
Angle20 degree
Length26 Millimeter
Angle20 degree
Length26 Millimeter
Angle20 degree
Length26 Millimeter
Angle20 degree
Length26 Millimeter
Angle20 degree
Length26 Millimeter
Angle20 degree
Length26 Millimeter
Angle20 degree
Length26 Millimeter
Angle20 degree
Length26 Millimeter
Angle20 degree
Length26 Millimeter
Angle20 degree
Length26 Millimeter
Angle20 degree
Length26 Millimeter
Angle20 degree
Length26 Millimeter
Angle20 degree
Length26 Millimeter
Angle20 degree
Length26 Millimeter
Angle20 degree
Length26 Millimeter
Angle20 degree
Length26 Millimeter
Angle20 degree
Length26 Millimeter
Angle20 degree
Length26 Millimeter
Angle20 degree
Length26 Millimeter
Angle20 degree
Length26 Millimeter
Angle20 degree
Length26 Millimeter
Angle20 degree
Length26 Millimeter
Angle20 degree
Length26 Millimeter
Angle20 degree
Length26 Millimeter
Angle20 degree
Length26 Millimeter
Angle20 degree
Length26 Millimeter
Angle20 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100195860010686 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, fixation, spinal intervertebral body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00195860010686]

Moist Heat or Steam Sterilization

[00195860010686]

Moist Heat or Steam Sterilization

[00195860010686]

Moist Heat or Steam Sterilization

[00195860010686]

Moist Heat or Steam Sterilization

[00195860010686]

Moist Heat or Steam Sterilization

[00195860010686]

Moist Heat or Steam Sterilization

[00195860010686]

Moist Heat or Steam Sterilization

[00195860010686]

Moist Heat or Steam Sterilization

[00195860010686]

Moist Heat or Steam Sterilization

[00195860010686]

Moist Heat or Steam Sterilization

[00195860010686]

Moist Heat or Steam Sterilization

[00195860010686]

Moist Heat or Steam Sterilization

[00195860010686]

Moist Heat or Steam Sterilization

[00195860010686]

Moist Heat or Steam Sterilization

[00195860010686]

Moist Heat or Steam Sterilization

[00195860010686]

Moist Heat or Steam Sterilization

[00195860010686]

Moist Heat or Steam Sterilization

[00195860010686]

Moist Heat or Steam Sterilization

[00195860010686]

Moist Heat or Steam Sterilization

[00195860010686]

Moist Heat or Steam Sterilization

[00195860010686]

Moist Heat or Steam Sterilization

[00195860010686]

Moist Heat or Steam Sterilization

[00195860010686]

Moist Heat or Steam Sterilization

[00195860010686]

Moist Heat or Steam Sterilization

[00195860010686]

Moist Heat or Steam Sterilization

[00195860010686]

Moist Heat or Steam Sterilization

[00195860010686]

Moist Heat or Steam Sterilization

[00195860010686]

Moist Heat or Steam Sterilization

[00195860010686]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-21
Device Publish Date2021-06-12

On-Brand Devices [Vail ALIF Buttress Plate System]

00195860010839Buttress Plate Caddy
00195860010822Buttress Tap
00195860010815Buttress Cover Turner Driver
00195860010808Buttress Screwdriver
00195860010792Buttress Inserter / Awl
00195860010785Dia 5.5 x 25mm Screw
00195860010778Dia 5.5 x 20mm Screw
0019586001076126mm 30 Deg Buttress Plate
0019586001075424mm 30 Deg Buttress Plate
0019586001074722mm 30 Deg Buttress Plate
0019586001073020mm 30 Deg Buttress Plate
0019586001072326mm 25 Deg Buttress Plate
0019586001071624mm 25 Deg Buttress Plate
0019586001070922mm 25 Deg Buttress Plate
0019586001069320mm 25 Deg Buttress Plate
0019586001068626mm 20 Deg Buttress Plate
0019586001067924mm 20 Deg Buttress Plate
0019586001066222mm 20 Deg Buttress Plate
0019586001065520mm 20 Deg Buttress Plate
0019586001064826mm 6 Deg Buttress Plate
0019586001063124mm 6 Deg Buttress Plate
0019586001062422mm 6 Deg Buttress Plate
0019586001061720mm 6 Deg Buttress Plate
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.