Tomcat Spinal System

GUDID 00840996177252

TomCat Angled Driver Grip

Choice Spine, LP

Metallic spinal fusion cage, non-sterile
Primary Device ID00840996177252
NIH Device Record Key6de5b158-63e3-467c-a64f-c3f474744324
Commercial Distribution StatusIn Commercial Distribution
Brand NameTomcat Spinal System
Version Model NumberR070-0031
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996177252 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996177252]

Moist Heat or Steam Sterilization

[00840996177252]

Moist Heat or Steam Sterilization

[00840996177252]

Moist Heat or Steam Sterilization

[00840996177252]

Moist Heat or Steam Sterilization

[00840996177252]

Moist Heat or Steam Sterilization

[00840996177252]

Moist Heat or Steam Sterilization

[00840996177252]

Moist Heat or Steam Sterilization

[00840996177252]

Moist Heat or Steam Sterilization

[00840996177252]

Moist Heat or Steam Sterilization

[00840996177252]

Moist Heat or Steam Sterilization

[00840996177252]

Moist Heat or Steam Sterilization

[00840996177252]

Moist Heat or Steam Sterilization

[00840996177252]

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

Devices Manufactured by Choice Spine, LP

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00840996176576 - Boomerang2026-01-23 BOOMERANG SELF DRILLING SCREWS 4.54X 17
00840996176583 - BOOMERANG2026-01-23 BOOMERANG PLATE HOLDER
00840996176590 - BOOMERANG2026-01-23 BOOMERANG DRILL, 10MM
00840996176606 - Boomerang2026-01-23 Boomerang Combination Drill/Awl AO
00840996182119 - HARRIER-SA Lumbar Interbody System2024-03-05 HARRIER-SA,DRIVER,SPLIT-TIP
00840996150682 - Acapella One2024-03-04 ACAPELLA,TRIAL,LR,NS,12X14X5
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