Zavation

GUDID 00842166182646

LEIF Sizer 9 x 27 x 5 deg - 09

ZAVATION LLC

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage
Primary Device ID00842166182646
NIH Device Record Key9fb10d41-5245-4019-8c69-b1ae57080447
Commercial Distribution StatusIn Commercial Distribution
Brand NameZavation
Version Model Number160s-092705-09
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100842166182646 [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

[00842166182646]

Moist Heat or Steam Sterilization


[00842166182646]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-24
Device Publish Date2019-03-22

On-Brand Devices [Zavation]

00084216611481TLIF 30, 6deg -15
00842166176768MIS Caliper
00842166176607MIS Compressor/Distractor
0084216617659125mm Dilator
0084216617658422mm Dilator
0084216617657719mm Dilator
0084216617656016mm Dilator
0084216617655313mm Dilator
0084216617654610mm Dilator
00842166176508K-Wire, Blunt, Smooth
00842166176225Parellel Distractor for 6.0mm
00842166176218Parallel Compressor
00842166176119Caliper
00842166176058Large-T Torque Limiting Handle
00842166175167Custom Distractor
00842166118324Rod Cutter, 3.5mm
00842166118317Torque Limiting Axial Handle, 25 in-lbs
00842166118294Straight Handle, Spinner top
00842166118270Rod Persuader, 3.5mm
00842166118263Hook, Offset, Crosslink Inserter, scissor type
00842166118249Rod Rocker
00842166118225Hook Trial, 6.0mm
00842166118218Hook Trial, 4.5mm
00842166118195Torque Shaft, T-15
00842166118188Set Screw Inserter, T-15
00842166118171Polyaxial Screwdriver, 2.5mm straight hex - large handle
00842166118164Polyaxial Screwdriver, 2.5mm straight hex - small handle
00842166118140Tap 4.0mm
00842166118133Tap 3.5mm
00842166118126Tap 3.0mm
00842166118119Screw Head Positioner
00842166118041Drill Guide - 10-52mm height range
00842166118034Awl - 2.0mm (0.078") diameter, 6mm tip length
00842166118027Polyaxial Shaft Screw 4.0x50mm
00842166118010Polyaxial Shaft Screw 4.0x48mm
00842166118003Polyaxial Shaft Screw 4.0x46mm
00842166117990Polyaxial Shaft Screw 4.0x44mm
00842166117983Polyaxial Shaft Screw 4.0x42mm
00842166117976Polyaxial Shaft Screw 4.0x40mm
00842166117969Polyaxial Shaft Screw 4.0x38mm
00842166117952Polyaxial Shaft Screw 4.0x36mm
00842166117945Polyaxial Shaft Screw 4.0x34mm
00842166117938Polyaxial Shaft Screw 4.0x32mm
00842166117921Polyaxial Shaft Screw 4.0x30mm
00842166117914Polyaxial Shaft Screw 4.0x28mm
00842166117907Polyaxial Shaft Screw 4.0x26mm
00842166117891Polyaxial Shaft Screw 4.0x24mm
00842166117884Polyaxial Shaft Screw 4.0x22mm
00842166117877Polyaxial Shaft Screw 4.0x20mm
008421661178603.5mm x 50mm Polyaxial Shaft Screw

Trademark Results [Zavation]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ZAVATION
ZAVATION
85217926 not registered Dead/Abandoned
Zavation, Inc.
2011-01-14

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