FDA.reportPublic FDA data

ZAVATION TRIAL

Primary DI
00197157077709
Brand
ZAVATION TRIAL
Company
Zavation LLC
Model
02T01029
Device description
20° ANGLED TRIAL - FOUNDATION 3D TLIF - 37mm X 10mm X 14mm, 6°
Published
2026-05-19
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
K162496000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162496000Foundation 3D InterbodyCorelink, LLC2017-05-04ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197157077709PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157077709001971570777091971570777090197157077709

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
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
00810017916191SABER-XA, Expandable Spacer, 37x28mm, 16mm, (18°)ELEVATION SPINE, INC.MAX2026-10-27
08809974869284Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809885799977Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809885799984Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809885799991Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974779934Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974779941Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974779958Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974779965Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974779972Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974779989Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974779996Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974789957Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974789964Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974789971Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974789988Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974789995Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799864Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799871Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799888Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799895Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799901Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799918Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799925Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799932Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799949Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799956Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799963Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799970Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799987Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18