FDA.reportPublic FDA data

Zavation

Primary DI
00842166148703
Brand
Zavation
Company
Zavation LLC
Model
30-0240SP
Device description
2-Level Cervical Plate 40mm Sterile Packed
Published
2020-03-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181244000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181244000Zavation Cervical Plate SystemZavation Medical Products, LLC2018-07-10KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842166148703PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842166148703008421661487038421661487030842166148703

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

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
00197157059521ZAVATION RODR5522-0852026-06-04
00197157059538ZAVATION RODR5522-0902026-06-04
00197157059545ZAVATION RODR5522-0952026-06-04
00197157059552ZAVATION RODR5522-1002026-06-04
00197157059569ZAVATION RODR5522-1052026-06-04
00197157059576ZAVATION RODR5522-1102026-06-04
00197157059583ZAVATION RODR5522-1152026-06-04
00197157059590ZAVATION RODR5522-1202026-06-04
00197157059606ZAVATION RODR5522-1252026-06-04
00197157059613ZAVATION RODR5522-1302026-06-04

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