Zavation Medical Products, LLC

GUDID 00842166197084

Set Screw Torque Shaft

ZAVATION LLC

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00842166197084
NIH Device Record Keyd7011995-a2ed-4c17-93f3-6fcc157c079c
Commercial Distribution StatusIn Commercial Distribution
Brand NameZavation Medical Products, LLC
Version Model NumberZAV-1287
Company DUNS069472800
Company NameZAVATION 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 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

Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100842166197084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAppliance, Fixation, Spinal Interlaminal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

[00842166197084]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-27
Device Publish Date2023-12-19

On-Brand Devices [Zavation Medical Products, LLC]

00842166195301SIBI Instrument Tray
00842166187023INSERTER
00842166187931SIBI CAGE
00842166188747BLUNT TIP DILATOR 2
00842166189331Dilator 1
00842166189928TAMP
00842166191853BOX CHISEL
00842166192379SMALL MALLET
00842166186309Inserter
00842166186293Mallet
00842166186194DRILL
00842166186187RASP
00842166186170BOX CHISEL
00842166186163TAMP
00842166186156DILATOR 2
00842166186149DILATOR 1
00842166186132STEINMANN PIN
00842166197107Set Screw Inserter
00842166197091Drill Guide
00842166197084Set Screw Torque Shaft
008421661970772.5mm Screw Driver-Posterior Cervical
008421661970602.5mm Screw Driver-Posterior Cervical
008421661970532.5mm Screw Driver-Posterior Cervical
00842166197046Anti-Torque/Posterior Cervical
00842166197039Set Screw Inserter
008421661970223.5MM Drill-Posterior Cervical
008421661970153.0MM Drill-Posterior Cervical
008421661970082.5MM Drill-Posterior Cervical
008421661969952.0MM Drill-Posterior Cervical
0084216619698814x16 Custom Lasered Sizer, 9 & 10MM
0084216619697114x16 Custom Lasered Sizer, 7 & 8MM
0084216619696414x16 Custom Lasered Sizer, 5 & 6MM
0084216619695712x14 Custom Lasered Sizer, 9 & 10MM
0084216619694012x14 Custom Lasered Sizer, 7 & 8MM
0084216619693312x14 Custom Lasered Sizer, 5 & 6MM
00842166196926Rod Persuader Short
00842166196919SI Screw Wrench
00842166196902Custom Rod Rocker
00842166196896eZspand Removal Tool
00842166196889Custom Rod Rocker
008421661968722.5mm K-Wire/Long
00842166196858Torque Rod
00842166196841Inserter Handle
00842166196834Spike, Threaded Tip
00842166196827Spike, Smooth Tip
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