FDA.reportPublic FDA data

ZAVATION DILATOR

Primary DI
00197157067342
Brand
ZAVATION DILATOR
Company
Zavation LLC
Model
2040-255
Device description
SACROILIAC - #5 DILATOR, 90° HANDLE
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
OURSacroiliac Joint Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OURSacroiliac Joint FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152237000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152237000The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC2016-02-04OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197157067342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157067342001971570673421971570673420197157067342

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar interspinous decompression instrument set, reusableA collection of surgical instruments and devices intended to be used for the implantation of an interspinous process decompression (IPD) implant that is inserted between two adjacent lumbar spinous processes during a minimally-invasive procedure to decompress neural structures; this is typically to treat a patient suffering from symptomatic degenerative lumbar spinal stenosis (DLSS). It typically consists of a tray, dedicated dilators, a sizing instrument, a spacer (the implant) insertion instrument, implant holders, and a torque-limiting screwdriver. This is a reusable device.

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
Serial number
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

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M719G120040SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
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M719GL201TL0SIros-XGenesys Orthopedics Systems LLCOUR2026-07-23
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