FDA.reportPublic FDA data

Zavation

Primary DI
00197157006341
Brand
Zavation
Company
Zavation LLC
Model
ZAV-1335
Device description
Dilator 2-S
Published
2023-12-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone
OURSacroiliac Joint Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2
OURSacroiliac Joint FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173752000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173752000SI Screw SystemZavation Medical Products, LLC2018-03-16OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197157006341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157006341001971570063411971570063410197157006341

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
601-919-1119info@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
00196449002511LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002528LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002535LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002542LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002559LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002566LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002573LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002580LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002597LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002603LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002610LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002627LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002634LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002641LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002658LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002665LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002672LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002689LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002696LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002702LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002719LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002726LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002733LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002740LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002757LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002764LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002771LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002788LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002795LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002801LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08