FDA.reportPublic FDA data

Zavation

Primary DI
00842166171565
Brand
Zavation
Company
Zavation LLC
Model
695-4012
Device description
Self Tapping Variable Screw, 4mmx12
Published
2022-10-11
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
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221049000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221049000Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC2022-08-12OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842166171565PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842166171565008421661715658421661715650842166171565

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776391720CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391737CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391744CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391751CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391768CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391775CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391782CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391799CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391805CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391812CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391829CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391836CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391843CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391850CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391867CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391874CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391881CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391898CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391904CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391911CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391928CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391935CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391942CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391959CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391966CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391973CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391980CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391997CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776392000CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776392017CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11