FDA.reportPublic FDA data

Zavation

Primary DI
00842166195356
Brand
Zavation
Company
Zavation LLC
Model
259-9001-C7
Device description
18mm Rectangular Plates Caddy
Published
2022-02-15
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
MQPSpinal Vertebral Body Replacement Device
PLRSpinal Vertebral Body Replacement Device - Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2
PLRSpinal Vertebral Body Replacement Device - CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180673000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180673000Normandy VBR SystemZavation Medical Products, LLC2018-07-13PLR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842166195356PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842166195356008421661953568421661953560842166195356

GMDN Terms#

Term, Definition table
TermDefinition
Posterior lumbar spine prosthesisA sterile implantable device designed to replace anatomical structures removed from the posterior aspect of lumbar vertebrae (i.e., the lamina, facet joint, and bony elements) during spinal decompression surgery to provide stability to, and enable normal range of motion of, the lumbar spine. It consists of a two-plate unit positioned in the posterior midline, which connects horizontal rods that are attached laterally to adjacent vertebrae with pedicle screws; the plates include interlocking trunnions for rotational/angular motion. The device may be a single unit or modular assembled during implantation. Dedicated tools for implantation are 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
00197157082031ZAVATION SCREW35045-302026-06-05
00197157082048ZAVATION SCREW35045-322026-06-05
00197157082055ZAVATION SCREW35045-342026-06-05
00197157082062ZAVATION SCREW35045-362026-06-05
00197157082079ZAVATION SCREW35045-382026-06-05
00197157082086ZAVATION SCREW35045-402026-06-05
00197157082093ZAVATION SCREW35045-422026-06-05
00197157082109ZAVATION SCREW35045-442026-06-05
00197157082116ZAVATION SCREW35045-462026-06-05
00197157082123ZAVATION SCREW35045-482026-06-05
00197157081515ZAVATION SCREW35035-102026-06-04
00197157081522ZAVATION SCREW35035-122026-06-04
00197157081539ZAVATION SCREW35035-142026-06-04
00197157081546ZAVATION SCREW35035-162026-06-04
00197157081553ZAVATION SCREW35035-182026-06-04
00197157081560ZAVATION SCREW35035-202026-06-04
00197157081577ZAVATION SCREW35035-222026-06-04
00197157081584ZAVATION SCREW35035-242026-06-04
00197157081591ZAVATION SCREW35035-262026-06-04
00197157081607ZAVATION SCREW35035-282026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18257200151271CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151288CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151295CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151325CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151349CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151356CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151363CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151370CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151387CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151394CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151424CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151431CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151448CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151455CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151462CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151479CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151493CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151509CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151523CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151530CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151547CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151561CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151578CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151585CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151592CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151608CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151615CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151622CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151639CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151646CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17