FDA.reportPublic FDA data

ZAVATION INSERTER

Primary DI
00197157072025
Brand
ZAVATION INSERTER
Company
Zavation LLC
Model
954-1003-2
Device description
SHAFT - INNER NANOPRIME LABYRINTH PLIF INSERTER, SLIDE HAMMER ATTACHMENT
Published
2025-09-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00197157072025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157072025001971570720251971570720250197157072025

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic inorganic implant inserter/extractor, reusableA hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
00197157075835ZAVATION DRIVERZAV-13982026-05-27
00197157075842ZAVATION K-WIREZAV-13972026-05-27
00197157075859ZAVATION INSERTERZAV-10552026-05-27
00197157068332ZAVATION INSTRUMENT TRAY14T009142026-05-20
00197157068349ZAVATION INSTRUMENT TRAY14T009152026-05-20
00197157068356ZAVATION INSTRUMENT TRAY14T009162026-05-20
00197157068363ZAVATION INSTRUMENT TRAY14T009172026-05-20
00197157068370ZAVATION INSTRUMENT TRAY14T009192026-05-20
00197157068387ZAVATION INSTRUMENT TRAY14T009202026-05-20
00197157068394ZAVATION INSTRUMENT TRAY14T009212026-05-20
00197157068400ZAVATION INSTRUMENT TRAY14T009222026-05-20
00197157068417ZAVATION INSTRUMENT TRAY14T009242026-05-20
00197157068424ZAVATION INSTRUMENT TRAY14T009252026-05-20
00197157068431ZAVATION INSTRUMENT TRAY14T009262026-05-20
00197157068448ZAVATION INSTRUMENT TRAY14T009272026-05-20
00197157068455ZAVATION INSTRUMENT TRAY14T009282026-05-20
00197157068462ZAVATION TAPZAV-1381-302026-05-20
00197157068479ZAVATION TAPZAV-1381-352026-05-20
00197157068486ZAVATION TAPZAV-1381-402026-05-20
00197157068493ZAVATION INSTRUMENT989-2032-42026-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157075859ZAVATION INSERTERZavation LLCMAX2026-05-27
00810166522366X-PACEXPANDING INNOVATIONS, INC.MAX2026-05-27
00810166522373X-PACEXPANDING INNOVATIONS, INC.MAX2026-05-27
B70712535005S0Dual X Graft Tamp ShortAMPLIFY SURGICAL, INC.MAX2026-05-27
B707129410010130DUALXS T/PLIF 15 DEG x 9-12MMAMPLIFY SURGICAL, INC.MAX2026-05-27
B707129410010200DUALXS T/PLIF 18 DEG x 10-13MMAMPLIFY SURGICAL, INC.MAX2026-05-27
07613153046196AVS PLStryker CorporationMAX2015-09-14
07613153046202AVS PLStryker CorporationMAX2015-09-14
07613153046219AVS PLStryker CorporationMAX2015-09-14
07613153046233AVS PLStryker CorporationMAX2015-09-14
07613153046301AVS PLStryker CorporationMAX2015-09-14
07613153046325AVS PLStryker CorporationMAX2015-09-14
07613153046332AVS PLStryker CorporationMAX2015-09-14
07613153046356AVS PLStryker CorporationMAX2015-09-14
07613153046363AVS PLStryker CorporationMAX2015-09-14
07613153046394AVS TLStryker CorporationMAX2015-09-14
07613153046400AVS TLStryker CorporationMAX2015-09-14
07613153046417AVS TLStryker CorporationMAX2015-09-14
07613153046424AVS TLStryker CorporationMAX2015-09-14
07613153046431AVS TLStryker CorporationMAX2015-09-14
07613153046448AVS TLStryker CorporationMAX2015-09-14
07613153046455AVS TLStryker CorporationMAX2015-09-14
07613153046462AVS TLStryker CorporationMAX2015-09-14
07613153046479AVS TLStryker CorporationMAX2015-09-14
07613153046486AVS TLStryker CorporationMAX2015-09-14
07613153046493AVS TLStryker CorporationMAX2015-09-14
07613153046509AVS TLStryker CorporationMAX2015-09-14
07613153046530AVS TLStryker CorporationMAX2015-09-14
07613153046547AVS TLStryker CorporationMAX2015-09-14
07613153046578AVS TLStryker CorporationMAX2015-09-14