FDA.reportPublic FDA data

Zavation

Primary DI
00197157006587
Brand
Zavation
Company
Zavation LLC
Model
ZAV-1345
Device description
Custom Distracting Inserter
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
KWPAppliance, Fixation, Spinal Interlaminal
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112484000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112484000ZAVATION SPINAL SYSTEMZavation, LLC2011-11-22MNI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197157006587PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157006587001971570065871971570065870197157006587

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
M719GL3110TiLockGenesys Orthopedics Systems LLCMNI2026-08-03
M719GL3110TiLockGenesys Orthopedics Systems LLCMNH2026-08-03
M719GLC403S0TiLockGenesys Orthopedics Systems LLCMNI2026-08-03
M719GLC403S0TiLockGenesys Orthopedics Systems LLCMNH2026-08-03
00763000992026MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-08-02
00763000992026MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-08-02
00763000992026MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-08-02
00763000887216MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-07-30
00763000887216MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-07-30
00763000887216MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-30
00840606189927OMEGA XPSPINAL ELEMENTS, INC.KWP2026-07-28
00841732168527TAURUS Pedicle Screw SystemCTL Medical CorporationMNH2026-07-28
00841732168527TAURUS Pedicle Screw SystemCTL Medical CorporationMNI2026-07-28
00841732168527TAURUS Pedicle Screw SystemCTL Medical CorporationKWP2026-07-28
00841732169272PICASSO MIS Spinal SystemCTL Medical CorporationMNH2026-07-24
00841732169272PICASSO MIS Spinal SystemCTL Medical CorporationMNI2026-07-24
00841732169289PICASSO MIS Spinal SystemCTL Medical CorporationMNI2026-07-24
00841732169289PICASSO MIS Spinal SystemCTL Medical CorporationMNH2026-07-24
00841732169296PICASSO MIS Spinal SystemCTL Medical CorporationMNH2026-07-24
00841732169296PICASSO MIS Spinal SystemCTL Medical CorporationMNI2026-07-24
00841732169302PICASSO MIS Spinal SystemCTL Medical CorporationMNI2026-07-24
00841732169302PICASSO MIS Spinal SystemCTL Medical CorporationMNH2026-07-24
00841732169319PICASSO MIS Spinal SystemCTL Medical CorporationMNI2026-07-24
00841732169319PICASSO MIS Spinal SystemCTL Medical CorporationMNH2026-07-24
10888857598164Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598171Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598188Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598195Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598201Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598218Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24