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
00197157082031ZAVATION SCREW35045-302026-06-05
00197157082048ZAVATION SCREW35045-322026-06-05
00197157082055ZAVATION SCREW35045-342026-06-05
00197157082062ZAVATION SCREW35045-362026-06-05
00197157082079ZAVATION SCREW35045-382026-06-05
00197157082086ZAVATION SCREW35045-402026-06-05
00197157082093ZAVATION SCREW35045-422026-06-05
00197157082109ZAVATION SCREW35045-442026-06-05
00197157082116ZAVATION SCREW35045-462026-06-05
00197157082123ZAVATION SCREW35045-482026-06-05
00197157081515ZAVATION SCREW35035-102026-06-04
00197157081522ZAVATION SCREW35035-122026-06-04
00197157081539ZAVATION SCREW35035-142026-06-04
00197157081546ZAVATION SCREW35035-162026-06-04
00197157081553ZAVATION SCREW35035-182026-06-04
00197157081560ZAVATION SCREW35035-202026-06-04
00197157081577ZAVATION SCREW35035-222026-06-04
00197157081584ZAVATION SCREW35035-242026-06-04
00197157081591ZAVATION SCREW35035-262026-06-04
00197157081607ZAVATION SCREW35035-282026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000704452MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000704537MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000880897MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000881153MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000881382MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000881399MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000881405MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
18257200076871FORZAOrthofix US LLCMAX2026-07-17
18257200076888FORZAOrthofix US LLCMAX2026-07-17
18257200076895FORZAOrthofix US LLCMAX2026-07-17
18257200076901FORZAOrthofix US LLCMAX2026-07-17
18257200076918FORZAOrthofix US LLCMAX2026-07-17
18257200076925FORZAOrthofix US LLCMAX2026-07-17
18257200077007FORZAOrthofix US LLCMAX2026-07-17
18257200077038FORZAOrthofix US LLCMAX2026-07-17
18257200106028FORZAOrthofix US LLCMAX2026-07-17
18257200106035FORZAOrthofix US LLCMAX2026-07-17
18257200106042FORZAOrthofix US LLCMAX2026-07-17
18257200106066FORZAOrthofix US LLCMAX2026-07-17
18257200106073FORZAOrthofix US LLCMAX2026-07-17
18257200106080FORZAOrthofix US LLCMAX2026-07-17
18257200106097FORZAOrthofix US LLCMAX2026-07-17
18257200106103FORZAOrthofix US LLCMAX2026-07-17
18257200106141FORZAOrthofix US LLCMAX2026-07-17
18257200106158FORZAOrthofix US LLCMAX2026-07-17
18257200109432FORZA PTCOrthofix US LLCMAX2026-07-17
18257200136056FORZA XPOrthofix US LLCMAX2026-07-17
18257200136063FORZA XPOrthofix US LLCMAX2026-07-17
18257200136070FORZA XPOrthofix US LLCMAX2026-07-17
18257200151769FORZA TiOrthofix US LLCMAX2026-07-17