ZAVATION F3D CORPECTOMY

GUDID 00197157060015

F3D CORPECTOMY - 14.5MM X 12MM X 44MM, 0 DEG

Zavation LLC

Spinal fixation plate, non-bioabsorbable
Primary Device ID00197157060015
NIH Device Record Key859180be-739c-4a73-a08b-25595c0d658c
Commercial Distribution StatusIn Commercial Distribution
Brand NameZAVATION F3D CORPECTOMY
Version Model Number3CM1412-0044
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 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

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
GS100197157060015 [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

[00197157060015]

Radiation Sterilization

[00197157060015]

Radiation Sterilization

[00197157060015]

Radiation Sterilization

[00197157060015]

Radiation Sterilization

[00197157060015]

Radiation Sterilization

[00197157060015]

Radiation Sterilization

[00197157060015]

Radiation Sterilization

[00197157060015]

Radiation Sterilization

[00197157060015]

Radiation Sterilization

[00197157060015]

Radiation Sterilization

[00197157060015]

Radiation Sterilization

[00197157060015]

Radiation Sterilization

[00197157060015]

Radiation Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-21
Device Publish Date2025-07-11

On-Brand Devices [ZAVATION F3D CORPECTOMY]

00197157059712F3D CORPECTOMY - 14.5MM X 12MM X 14MM, 0 DEG
00197157060176F3D CORPECTOMY - 14.5MM X 12MM X 60MM, 0 DEG
00197157060169F3D CORPECTOMY - 14.5MM X 12MM X 59MM, 0 DEG
00197157060152F3D CORPECTOMY - 14.5MM X 12MM X 58MM, 0 DEG
00197157060145F3D CORPECTOMY - 14.5MM X 12MM X 57MM, 0 DEG
00197157060138F3D CORPECTOMY - 14.5MM X 12MM X 56MM, 0 DEG
00197157060121F3D CORPECTOMY - 14.5MM X 12MM X 55MM, 0 DEG
00197157060114F3D CORPECTOMY - 14.5MM X 12MM X 54MM, 0 DEG
00197157060107F3D CORPECTOMY - 14.5MM X 12MM X 53MM, 0 DEG
00197157060091F3D CORPECTOMY - 14.5MM X 12MM X 52MM, 0 DEG
00197157060084F3D CORPECTOMY - 14.5MM X 12MM X 51MM, 0 DEG
00197157060077F3D CORPECTOMY - 14.5MM X 12MM X 50MM, 0 DEG
00197157060060F3D CORPECTOMY - 14.5MM X 12MM X 49MM, 0 DEG
00197157060053F3D CORPECTOMY - 14.5MM X 12MM X 48MM, 0 DEG
00197157060046F3D CORPECTOMY - 14.5MM X 12MM X 47MM, 0 DEG
00197157060039F3D CORPECTOMY - 14.5MM X 12MM X 46MM, 0 DEG
00197157060022F3D CORPECTOMY - 14.5MM X 12MM X 45MM, 0 DEG
00197157060015F3D CORPECTOMY - 14.5MM X 12MM X 44MM, 0 DEG
00197157060008F3D CORPECTOMY - 14.5MM X 12MM X 43MM, 0 DEG
00197157059996F3D CORPECTOMY - 14.5MM X 12MM X 42MM, 0 DEG
00197157059989F3D CORPECTOMY - 14.5MM X 12MM X 41MM, 0 DEG
00197157059972F3D CORPECTOMY - 14.5MM X 12MM X 40MM, 0 DEG
00197157059965F3D CORPECTOMY - 14.5MM X 12MM X 39MM, 0 DEG
00197157059958F3D CORPECTOMY - 14.5MM X 12MM X 38MM, 0 DEG
00197157059941F3D CORPECTOMY - 14.5MM X 12MM X 37MM, 0 DEG
00197157059934F3D CORPECTOMY - 14.5MM X 12MM X 36MM, 0 DEG
00197157059927F3D CORPECTOMY - 14.5MM X 12MM X 35MM, 0 DEG
00197157059910F3D CORPECTOMY - 14.5MM X 12MM X 34MM, 0 DEG
00197157059903F3D CORPECTOMY - 14.5MM X 12MM X 33MM, 0 DEG
00197157059897F3D CORPECTOMY - 14.5MM X 12MM X 32MM, 0 DEG
00197157059880F3D CORPECTOMY - 14.5MM X 12MM X 31MM, 0 DEG
00197157059873F3D CORPECTOMY - 14.5MM X 12MM X 30MM, 0 DEG
00197157059866F3D CORPECTOMY - 14.5MM X 12MM X 29MM, 0 DEG
00197157059859F3D CORPECTOMY - 14.5MM X 12MM X 28MM, 0 DEG
00197157059842F3D CORPECTOMY - 14.5MM X 12MM X 27MM, 0 DEG
00197157059835F3D CORPECTOMY - 14.5MM X 12MM X 26MM, 0 DEG
00197157059828F3D CORPECTOMY - 14.5MM X 12MM X 25MM, 0 DEG
00197157059811F3D CORPECTOMY - 14.5MM X 12MM X 24MM, 0 DEG
00197157059804F3D CORPECTOMY - 14.5MM X 12MM X 23MM, 0 DEG
00197157059798F3D CORPECTOMY - 14.5MM X 12MM X 22MM, 0 DEG
00197157059781F3D CORPECTOMY - 14.5MM X 12MM X 21MM, 0 DEG
00197157059774F3D CORPECTOMY - 14.5MM X 12MM X 20MM, 0 DEG
00197157059767F3D CORPECTOMY - 14.5MM X 12MM X 19MM, 0 DEG
00197157059750F3D CORPECTOMY - 14.5MM X 12MM X 18MM, 0 DEG
00197157059743F3D CORPECTOMY - 14.5MM X 12MM X 17MM, 0 DEG
00197157059736F3D CORPECTOMY - 14.5MM X 12MM X 16MM, 0 DEG
00197157059729F3D CORPECTOMY - 14.5MM X 12MM X 15MM, 0 DEG
00197157060534F3D CORPECTOMY - 14.5MM X 12MM X 35MM, 7 DEG
00197157060527F3D CORPECTOMY - 14.5MM X 12MM X 34MM, 7 DEG
00197157060510F3D CORPECTOMY - 14.5MM X 12MM X 33MM, 7 DEG
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