SCS CLARIS Spinal Screws

GUDID 00840996121750

CLARIS,SCREW,POST,8.5X40

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840996121750
NIH Device Record Keyd713f8df-7118-4ffb-9b63-4cec0fb85c16
Commercial Distribution StatusIn Commercial Distribution
Brand NameSCS CLARIS Spinal Screws
Version Model Number2T10E8-40
Company DUNS078293017
Company NameChoice Spine, LP
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(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net

Device Dimensions

Outer Diameter8.5 Millimeter
Length40 Millimeter
Outer Diameter8.5 Millimeter
Length40 Millimeter
Outer Diameter8.5 Millimeter
Length40 Millimeter
Outer Diameter8.5 Millimeter
Length40 Millimeter
Outer Diameter8.5 Millimeter
Length40 Millimeter
Outer Diameter8.5 Millimeter
Length40 Millimeter
Outer Diameter8.5 Millimeter
Length40 Millimeter
Outer Diameter8.5 Millimeter
Length40 Millimeter
Outer Diameter8.5 Millimeter
Length40 Millimeter
Outer Diameter8.5 Millimeter
Length40 Millimeter
Outer Diameter8.5 Millimeter
Length40 Millimeter
Outer Diameter8.5 Millimeter
Length40 Millimeter
Outer Diameter8.5 Millimeter
Length40 Millimeter
Outer Diameter8.5 Millimeter
Length40 Millimeter
Outer Diameter8.5 Millimeter
Length40 Millimeter
Outer Diameter8.5 Millimeter
Length40 Millimeter
Outer Diameter8.5 Millimeter
Length40 Millimeter
Outer Diameter8.5 Millimeter
Length40 Millimeter
Outer Diameter8.5 Millimeter
Length40 Millimeter
Outer Diameter8.5 Millimeter
Length40 Millimeter
Outer Diameter8.5 Millimeter
Length40 Millimeter
Outer Diameter8.5 Millimeter
Length40 Millimeter
Outer Diameter8.5 Millimeter
Length40 Millimeter
Outer Diameter8.5 Millimeter
Length40 Millimeter
Outer Diameter8.5 Millimeter
Length40 Millimeter
Outer Diameter8.5 Millimeter
Length40 Millimeter
Outer Diameter8.5 Millimeter
Length40 Millimeter
Outer Diameter8.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996121750 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996121750]

Moist Heat or Steam Sterilization

[00840996121750]

Moist Heat or Steam Sterilization

[00840996121750]

Moist Heat or Steam Sterilization

[00840996121750]

Moist Heat or Steam Sterilization

[00840996121750]

Moist Heat or Steam Sterilization

[00840996121750]

Moist Heat or Steam Sterilization

[00840996121750]

Moist Heat or Steam Sterilization

[00840996121750]

Moist Heat or Steam Sterilization

[00840996121750]

Moist Heat or Steam Sterilization

[00840996121750]

Moist Heat or Steam Sterilization

[00840996121750]

Moist Heat or Steam Sterilization

[00840996121750]

Moist Heat or Steam Sterilization

[00840996121750]

Moist Heat or Steam Sterilization

[00840996121750]

Moist Heat or Steam Sterilization

[00840996121750]

Moist Heat or Steam Sterilization

[00840996121750]

Moist Heat or Steam Sterilization

[00840996121750]

Moist Heat or Steam Sterilization

[00840996121750]

Moist Heat or Steam Sterilization

[00840996121750]

Moist Heat or Steam Sterilization

[00840996121750]

Moist Heat or Steam Sterilization

[00840996121750]

Moist Heat or Steam Sterilization

[00840996121750]

Moist Heat or Steam Sterilization

[00840996121750]

Moist Heat or Steam Sterilization

[00840996121750]

Moist Heat or Steam Sterilization

[00840996121750]

Moist Heat or Steam Sterilization

[00840996121750]

Moist Heat or Steam Sterilization

[00840996121750]

Moist Heat or Steam Sterilization

[00840996121750]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-24

On-Brand Devices [SCS CLARIS Spinal Screws]

00840996122412SCS,CONNECTOR,LARGE
00840996122184CLARIS,SCREW,POST,REDUCT,NOBRK,7.5X55
00840996122177CLARIS,SCREW,POST,REDUCT,NOBRK,7.5X50
00840996122160CLARIS,SCREW,POST,REDUCT,NOBRK,5.5X55
00840996122153CLARIS,SCREW,POST,REDUCT,NOBRK,5.5X50
00840996122146CLARIS,SCREW,POST,REDUCTION,6.5X55
00840996122139CLARIS,SCREW,POST,REDUCTION,6.5X50
00840996122122CLARIS,SCREW,POST,REDUCTION,6.5X45
00840996122115CLARIS,SCREW,POST,REDUCTION,6.5X40
00840996122108CLARIS,SCREW,POST,REDUCTION,6.5X35
00840996122092CLARIS,SCREW,POST,8.5X55
00840996122085CLARIS,SCREW,POST,8.5X50
00840996122078CLARIS,SCREW,POST,8.5X45
00840996122061CLARIS,SCREW,POST,8.5X40
00840996122054CLARIS,SCREW,POST,7.0X50
00840996122047CLARIS,SCREW,POST,7.0X45
00840996122030CLARIS,SCREW,POST,7.0X40
00840996122023CLARIS,SCREW,POST,7.5X55
00840996122016CLARIS,SCREW,POST,7.5X50
00840996122009CLARIS,SCREW,POST,7.5X45
00840996121996CLARIS,SCREW,POST,7.5X40
00840996121989CLARIS,SCREW,POST,7.5X35
00840996121972CLARIS,SCREW,POST,7.5X30
00840996121965CLARIS,SCREW,POST,7.5X25
00840996121958CLARIS,SCREW,POST,6.5X55
00840996121941CLARIS,SCREW,POST,6.5X50
00840996121934CLARIS,SCREW,POST,6.5X45
00840996121927CLARIS,SCREW,POST,6.5X40
00840996121910CLARIS,SCREW,POST,6.5X35
00840996121903CLARIS,SCREW,POST,6.5X30
00840996121897CLARIS,SCREW,POST,5.5X55
00840996121880CLARIS,SCREW,POST,5.5X50
00840996121873CLARIS,SCREW,POST,5.5X45
00840996121866CLARIS,SCREW,POST,5.5X40
00840996121859CLARIS,SCREW,POST,5.5X35
00840996121842CLARIS,SCREW,POST,5.5X30
00840996121835CLARIS,SCREW,POST,9.5X55
00840996121828CLARIS,SCREW,POST,9.5X50
00840996121811CLARIS,SCREW,POST,9.5X45
00840996121804CLARIS,SCREW,POST,9.5X40
00840996121798CLARIS,SCREW,POST,9.5X35
00840996121781CLARIS,SCREW,POST,8.5X55
00840996121774CLARIS,SCREW,POST,8.5X50
00840996121767CLARIS,SCREW,POST,8.5X45
00840996121750CLARIS,SCREW,POST,8.5X40
00840996121743CLARIS,SCREW,POST,8.5X35
00840996121736CLARIS,SCREW,POST,7.5X55
00840996121729CLARIS,SCREW,POST,7.5X50
00840996121712CLARIS,SCREW,POST,7.5X45
00840996121705CLARIS,SCREW,POST,7.5X40
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