Zavation NanoPrime LABYRINTH CIF

GUDID 00197157040826

NanoPrime LABYRINTH CIF 14mmx18mm , 5deg , 7mm

Zavation LLC

Spinal fixation plate, non-bioabsorbable
Primary Device ID00197157040826
NIH Device Record Key3225afb9-7c4a-47e4-be08-d3b6013a90d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameZavation NanoPrime LABYRINTH CIF
Version Model Number953-0507
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 Usetrue
Lot Batchtrue
Serial Numbertrue
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

Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100197157040826 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00197157040826]

Radiation Sterilization

[00197157040826]

Radiation Sterilization

[00197157040826]

Radiation Sterilization

[00197157040826]

Radiation Sterilization

[00197157040826]

Radiation Sterilization

[00197157040826]

Radiation Sterilization

[00197157040826]

Radiation Sterilization

[00197157040826]

Radiation Sterilization

[00197157040826]

Radiation Sterilization

[00197157040826]

Radiation Sterilization

[00197157040826]

Radiation Sterilization

[00197157040826]

Radiation Sterilization

[00197157040826]

Radiation Sterilization

[00197157040826]

Radiation Sterilization

[00197157040826]

Radiation Sterilization

[00197157040826]

Radiation Sterilization

[00197157040826]

Radiation Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-01
Device Publish Date2024-09-23

On-Brand Devices [Zavation NanoPrime LABYRINTH CIF]

00197157039677NanoPrime LABYRINTH CIF 13mmx15mm , 0deg , 12mm
00197157039660NanoPrime LABYRINTH CIF 13mmx15mm , 0deg , 11mm
00197157039653NanoPrime LABYRINTH CIF 13mmx15mm , 0deg , 10mm
00197157039646NanoPrime LABYRINTH CIF 13mmx15mm , 0deg , 09mm
00197157039639NanoPrime LABYRINTH CIF 13mmx15mm , 0deg , 08mm
00197157039622NanoPrime LABYRINTH CIF 13mmx15mm , 0deg , 07mm
00197157039615NanoPrime LABYRINTH CIF 13mmx15mm , 0deg , 06mm
00197157039608NanoPrime LABYRINTH CIF 13mmx15mm , 0deg , 05mm
00197157039592NanoPrime LABYRINTH CIF 12mmx14mm , 10deg , 12mm
00197157039585NanoPrime LABYRINTH CIF 12mmx14mm , 10deg , 11mm
00197157039578NanoPrime LABYRINTH CIF 12mmx14mm , 10deg , 10mm
00197157039561NanoPrime LABYRINTH CIF 12mmx14mm , 10deg , 09mm
00197157039554NanoPrime LABYRINTH CIF 12mmx14mm , 10deg , 08mm
00197157039547NanoPrime LABYRINTH CIF 12mmx14mm , 10deg , 07mm
00197157039530NanoPrime LABYRINTH CIF 12mmx14mm , 10deg , 06mm
00197157039523NanoPrime LABYRINTH CIF 12mmx14mm , 10deg , 05mm
00197157039516NanoPrime LABYRINTH CIF 12mmx14mm , 9deg , 12mm
00197157039509NanoPrime LABYRINTH CIF 12mmx14mm , 9deg , 11mm
00197157039493NanoPrime LABYRINTH CIF 12mmx14mm , 9deg , 10mm
00197157039486NanoPrime LABYRINTH CIF 12mmx14mm , 9deg , 09mm
00197157039479NanoPrime LABYRINTH CIF 12mmx14mm , 9deg , 08mm
00197157039462NanoPrime LABYRINTH CIF 12mmx14mm , 9deg , 07mm
00197157039455NanoPrime LABYRINTH CIF 12mmx14mm , 9deg , 06mm
00197157039448NanoPrime LABYRINTH CIF 12mmx14mm , 9deg , 05mm
00197157039431NanoPrime LABYRINTH CIF 12mmx14mm , 8deg , 12mm
00197157039424NanoPrime LABYRINTH CIF 12mmx14mm , 8deg , 11mm
00197157039417NanoPrime LABYRINTH CIF 12mmx14mm , 8deg , 10mm
00197157039400NanoPrime LABYRINTH CIF 12mmx14mm , 8deg , 09mm
00197157039394NanoPrime LABYRINTH CIF 12mmx14mm , 8deg , 08mm
00197157039387NanoPrime LABYRINTH CIF 12mmx14mm , 8deg , 07mm
00197157039370NanoPrime LABYRINTH CIF 12mmx14mm , 8deg , 06mm
00197157039363NanoPrime LABYRINTH CIF 12mmx14mm , 8deg , 05mm
00197157039356NanoPrime LABYRINTH CIF 12mmx14mm , 7deg , 12mm
00197157039349NanoPrime LABYRINTH CIF 12mmx14mm , 7deg , 11mm
00197157039332NanoPrime LABYRINTH CIF 12mmx14mm , 7deg , 10mm
00197157039325NanoPrime LABYRINTH CIF 12mmx14mm , 7deg , 09mm
00197157039318NanoPrime LABYRINTH CIF 12mmx14mm , 7deg , 08mm
00197157039301NanoPrime LABYRINTH CIF 12mmx14mm , 7deg , 07mm
00197157039295NanoPrime LABYRINTH CIF 12mmx14mm , 7deg , 06mm
00197157039288NanoPrime LABYRINTH CIF 12mmx14mm , 7deg , 05mm
00197157039271NanoPrime LABYRINTH CIF 12mmx14mm , 6deg , 12mm
00197157039264NanoPrime LABYRINTH CIF 12mmx14mm , 6deg , 11mm
00197157039257NanoPrime LABYRINTH CIF 12mmx14mm , 6deg , 10mm
00197157039240NanoPrime LABYRINTH CIF 12mmx14mm , 6deg , 09mm
00197157039233NanoPrime LABYRINTH CIF 12mmx14mm , 6deg , 08mm
00197157039226NanoPrime LABYRINTH CIF 12mmx14mm , 6deg , 07mm
00197157039219NanoPrime LABYRINTH CIF 12mmx14mm , 6deg , 06mm
00197157039202NanoPrime LABYRINTH CIF 12mmx14mm , 6deg , 05mm
00197157039196NanoPrime LABYRINTH CIF 12mmx14mm , 5deg , 12mm
00197157039189NanoPrime LABYRINTH CIF 12mmx14mm , 5deg , 11mm
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