FDA.reportPublic FDA data

Zavation

Primary DI
00197157002961
Brand
Zavation
Company
Zavation LLC
Model
23-0912
Device description
CIF 14x18, 9 deg, -12
Published
2023-03-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162206000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162206000Zavation IBFZavation, LLC2017-04-04MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197157002961PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157002961001971570029611971570029610197157002961

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
601-919-1119info@zavation.com

Regulatory Flags#

DUNS number
069472800
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197157123611ZAVATION SCREW1010-C-075070-S-C2026-10-21
00197157123628ZAVATION SCREW1010-C-075075-S-C2026-10-21
00197157123635ZAVATION SCREW1010-C-075080-S-C2026-10-21
00197157123642ZAVATION SCREW1010-C-075085-S-C2026-10-21
00197157123659ZAVATION SCREW1010-C-075090-S-C2026-10-21
00197157123666ZAVATION SCREW1010-C-075095-S-C2026-10-21
00197157122874ZAVATION SCREW1010-C-065060-C-C2026-10-20
00197157122881ZAVATION SCREW1010-C-065065-C-C2026-10-20
00197157122898ZAVATION SCREW1010-C-065070-C-C2026-10-20
00197157122904ZAVATION SCREW1010-C-065075-C-C2026-10-20
00197157122911ZAVATION SCREW1010-C-065080-C-C2026-10-20
00197157122928ZAVATION SCREW1010-C-065085-C-C2026-10-20
00197157122935ZAVATION SCREW1010-C-065090-C-C2026-10-20
00197157122942ZAVATION SCREW1010-C-065095-C-C2026-10-20
00197157122959ZAVATION SCREW1010-C-065100-C-C2026-10-20
00197157122966ZAVATION SCREW1010-C-065105-C-C2026-10-20
00197157122973ZAVATION SCREW1010-C-065110-C-C2026-10-20
00197157122980ZAVATION SCREW1010-C-065025-C-S2026-10-20
00197157122997ZAVATION SCREW1010-C-065030-C-S2026-10-20
00197157123000ZAVATION SCREW1010-C-065035-C-S2026-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017916139SABER-XA, Anterior Plate, 34Wx11HELEVATION SPINE, INC.MAX2026-10-23
00810017916146SABER-XA, Anterior Plate, 34Wx13HELEVATION SPINE, INC.MAX2026-10-23
00810017916153SABER-XA, Anterior Plate, 34Wx16HELEVATION SPINE, INC.MAX2026-10-23
00810017916207SABER-XA, Anterior Plate, 37Wx11HELEVATION SPINE, INC.MAX2026-10-23
00810017916221SABER-XA, Anterior Plate, 37Wx16HELEVATION SPINE, INC.MAX2026-10-23
00810017916276SABER-XA, Anterior Plate, 40Wx11HELEVATION SPINE, INC.MAX2026-10-23
00810017916283SABER-XA, Anterior Plate, 40Wx13HELEVATION SPINE, INC.MAX2026-10-23
00810017916290SABER-XA, Anterior Plate, 40Wx16HELEVATION SPINE, INC.MAX2026-10-23
00840606176347LucentSPINAL ELEMENTS, INC.MAX2026-10-22
00840606184847LucentSPINAL ELEMENTS, INC.MAX2026-10-22
00840606197106LucentSPINAL ELEMENTS, INC.MAX2026-10-22
B648C29510000Savant Lumbar Interbody Fusion SystemCURITEVA, INC.MAX2026-10-19
M719GLL11403DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-10-19
M719GLL11503DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-10-19
M719GLL11603DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-10-19
00810161900381EARP, 14X25X08 0°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900398EARP, 14X25X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900404EARP, 14X25X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900411EARP, 14X25X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900428EARP, 14X30X08 0°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900435EARP, 14X30X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900442EARP, 14X30X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900459EARP, 14X30X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900466EARP, 14X35X08 0°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
B6785221380Tranquil-L™NEXUS SPINE, L.L.C.MAX2021-12-17
B6785221390Tranquil-L™NEXUS SPINE, L.L.C.MAX2021-12-17
B6785221400Tranquil-L™NEXUS SPINE, L.L.C.MAX2021-12-17
B6785221410Tranquil-L™NEXUS SPINE, L.L.C.MAX2021-12-17
B6785221420Tranquil-L™NEXUS SPINE, L.L.C.MAX2021-12-17
B6785221430Tranquil-L™NEXUS SPINE, L.L.C.MAX2021-12-17