RAVEN LUMBAR PLATE SYSTEM

GUDID 00840996177108

VARIABLE ANGLE DRIVER

Choice Spine, LP

Spinal fixation plate, non-bioabsorbable
Primary Device ID00840996177108
NIH Device Record Keyae4b0dd5-8db3-4994-af07-5d8a9b06882d
Commercial Distribution StatusIn Commercial Distribution
Brand NameRAVEN LUMBAR PLATE SYSTEM
Version Model NumberY070-1004
Company DUNS078293017
Company NameChoice Spine, LP
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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.com
Phone+1(865)246-3333
Emailinfo@choicespine.com
Phone+1(865)246-3333
Emailinfo@choicespine.com
Phone+1(865)246-3333
Emailinfo@choicespine.com
Phone+1(865)246-3333
Emailinfo@choicespine.com
Phone+1(865)246-3333
Emailinfo@choicespine.com
Phone+1(865)246-3333
Emailinfo@choicespine.com
Phone+1(865)246-3333
Emailinfo@choicespine.com
Phone+1(865)246-3333
Emailinfo@choicespine.com
Phone+1(865)246-3333
Emailinfo@choicespine.com
Phone+1(865)246-3333
Emailinfo@choicespine.com
Phone+1(865)246-3333
Emailinfo@choicespine.com
Phone+1(865)246-3333
Emailinfo@choicespine.com
Phone+1(865)246-3333
Emailinfo@choicespine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996177108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996177108]

Moist Heat or Steam Sterilization

[00840996177108]

Moist Heat or Steam Sterilization

[00840996177108]

Moist Heat or Steam Sterilization

[00840996177108]

Moist Heat or Steam Sterilization

[00840996177108]

Moist Heat or Steam Sterilization

[00840996177108]

Moist Heat or Steam Sterilization

[00840996177108]

Moist Heat or Steam Sterilization

[00840996177108]

Moist Heat or Steam Sterilization

[00840996177108]

Moist Heat or Steam Sterilization

[00840996177108]

Moist Heat or Steam Sterilization

[00840996177108]

Moist Heat or Steam Sterilization

[00840996177108]

Moist Heat or Steam Sterilization

[00840996177108]

Moist Heat or Steam Sterilization

[00840996177108]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-28
Device Publish Date2019-06-20

On-Brand Devices [RAVEN LUMBAR PLATE SYSTEM]

00840996177153LATERAL PLATE SYSTEM -3.0MM DRILL
00840996177146STRAIGHT DRIVER LUMBAR PLATE SYSTEM
00840996177139ANTERIOR PLATE/CAGE INSERTER
00840996177122LATERAL PLATE INSERTER L15-23MM
00840996177115AWL/DRILL 1/4" SQ
00840996177108VARIABLE ANGLE DRIVER
00840996177092STRAIGHT AWL LUMBAR PL SYS
00840996177085ANTERIOR OFFSET INSERTER
008409961769962 SCREW OFFSET LATERAL PLATE 23MM
008409961769722 SCREW OFFSET LATERAL PLATE 19MM
008409961769652 SCREW OFFSET LATERAL PLATE 17MM
008409961769582 SCREW OFFSET LATERAL PLATE 15MM
008409961769414 SCREW ANT PLATE 25MM
008409961769344 SCREW ANT PLATE 24MM
008409961769274 SCREW ANT PLATE 22MM
008409961769104 SCREW ANT PLATE 20MM
008409961769034 SCREW ANT PLATE 18MM
008409961768974 SCREW ANT PLATE 17MM
008409961768804SCREW ANT PLATE 15MM
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