FDA.reportPublic FDA data

ZAVATION PLATE

Primary DI
00197157075811
Brand
ZAVATION PLATE
Company
Zavation LLC
Model
21002-038
Device description
ANODYNE-SINGLE CERVICAL PLATE - 2 LEVEL, 38MM
Published
2026-05-12
Public version status
New
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
K132994000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132994000ANODYNE ANTERIOR CERVICAL PLATE SYSTEMCorelink, LLC2013-12-05KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197157075811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157075811001971570758111971570758110197157075811

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization as part of treatment of a spinal instability or deformity; it 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). Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
6019191119info@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
00197157116712ZAVATION SCREW1011-O-075040-F-C2026-09-18
00197157116729ZAVATION SCREW1011-O-075045-F-C2026-09-18
00197157116736ZAVATION SCREW1011-O-075050-F-C2026-09-18
00197157116743ZAVATION SCREW1011-O-075055-F-C2026-09-18
00197157116750ZAVATION SCREW1011-O-075060-F-C2026-09-18
00197157116767ZAVATION SCREW1011-O-075065-F-C2026-09-18
00197157116774ZAVATION SCREW1011-O-075070-F-C2026-09-18
00197157116781ZAVATION SCREW1011-O-075075-F-C2026-09-18
00197157116798ZAVATION SCREW1011-O-075080-F-C2026-09-18
00197157116804ZAVATION SCREW1011-O-075085-F-C2026-09-18
00197157116811ZAVATION SCREW1011-O-075090-F-C2026-09-18
00197157116828ZAVATION SCREW1011-O-075095-F-C2026-09-18
00197157116835ZAVATION SCREW1011-O-075100-F-C2026-09-18
00197157116842ZAVATION SCREW1011-O-075105-F-C2026-09-18
00197157116859ZAVATION SCREW1011-O-075110-F-C2026-09-18
00197157116866ZAVATION SCREW1011-O-075025-F-S2026-09-18
00197157116873ZAVATION SCREW1011-O-075030-F-S2026-09-18
00197157116880ZAVATION SCREW1011-O-075035-F-S2026-09-18
00197157116897ZAVATION SCREW1011-O-075040-F-S2026-09-18
00197157116903ZAVATION SCREW1011-O-075045-F-S2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000891428CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-09-20
00763000891480CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-09-20
10888857037953EVEREST® Spinal SystemVB Spine LLCKWQ2026-06-11
10888857037977EVEREST® Spinal SystemVB Spine LLCKWQ2026-06-11
10888857001428DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001435DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001459DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001657DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001688DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001695DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001701DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001718DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857046733MESA® Small Stature Spinal SystemVB Spine LLCKWQ2016-09-02
10888857008724EVEREST® Spinal SystemVB Spine LLCKWQ2016-03-10
10888857001497DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001527DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001589DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001619DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001640DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001725DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001763DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001787DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001824DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001848DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001923DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001947DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001978DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001992DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857002036DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857002050DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24