FDA.reportPublic FDA data

ZAVATION TRIAL

Primary DI
00197157071981
Brand
ZAVATION TRIAL
Company
Zavation LLC
Model
954-1001-WWLLAA-HH
Device description
TRIAL, NANOPRIME LABYRINTH PLIF
Published
2025-09-16
Public version status
New
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233509000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233509000Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF SystemZavation Medical Products, LLC2024-04-10MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197157071981PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157071981001971570719811971570719810197157071981

GMDN Terms#

Term, Definition table
TermDefinition
Internal spinal fixation force sensor trialA copy of a final internal spinal fixation force sensor, typically mounted on a handle, designed to be used to determine availability of adequate space for the fixation of the final temporary sensor used during the implantation procedure of an internal spinal fixation system. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
6019191119info@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
00197157082130ZAVATION SCREW35045-502026-07-23
00197157082147ZAVATION SCREW35740-102026-07-23
00197157082154ZAVATION SCREW35740-122026-07-23
00197157082161ZAVATION SCREW35740-142026-07-23
00197157082178ZAVATION SCREW35740-162026-07-23
00197157082185ZAVATION SCREW35740-182026-07-23
00197157082192ZAVATION SCREW35740-202026-07-23
00197157082208ZAVATION SCREW35740-222026-07-23
00197157082215ZAVATION SCREW35740-242026-07-23
00197157082222ZAVATION SCREW35740-262026-07-23
00197157082239ZAVATION SCREW35740-282026-07-23
00197157082246ZAVATION SCREW35740-302026-07-23
00197157082253ZAVATION SCREW35740-322026-07-23
00197157082260ZAVATION SCREW35740-342026-07-23
00197157082277ZAVATION SCREW35740-362026-07-23
00197157082284ZAVATION SCREW35740-382026-07-23
00197157082291ZAVATION SCREW35740-402026-07-23
00197157082307ZAVATION SCREW35740-422026-07-23
00197157082314ZAVATION SCREW35740-442026-07-23
00197157082321ZAVATION SCREW35740-462026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843511102852Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-18
00843511102869Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-18
00843511102876Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-18
00843511102883Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-18
00843511102890Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-18
00843511102906Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-18
00843511102913Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-18
00843511102920Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-18
00193982141097HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141103HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141110HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141127HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141134HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141141HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141158HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141165HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141172HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141189HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141196HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141202HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141240HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141257HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141264HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141271HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141288HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141295HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141301HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141318HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141325HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141332HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14